Merck and Schering-Plough Gets another Blow with Zetia and Vytorin Sidelining

Chicago -On Sunday, executives at Merck and Schering-Plough were visibly shocked when an expert panel here at the American College of Cardiology meeting told thousands of doctors not to use their top-selling drugs, Zetia and Vytorin. That night, at a press conference, they strongly contested arguments that they had not proved the drugs were safe.
On Monday morning, things got worse. Rival AstraZeneca said it had stopped its 15,000-patient clinical trial of its Crestor because an independent safety committee said there was proof the drug prevents heart attacks, strokes and deaths. The result came six months ahead of schedule.
Read the complete report at Forbes.

tag: Medical News, Merck, Schering-Plough, Zetia, Vytorin, straZeneca, Crestor

FDA Approves First Drug to Treat PKU (Phenylketonuria)

FDA has approved the first drug to treat phenylketonuria (PKU), which is a genetic disorder that affects one in about 15 thousand births in the U.S. The drug, called Kuvan (sapropterin dihydrochloride) was developed by BioMarin Pharmaceutical in partnership with Merck.

Those with PKU cannot metabolize phenylalanine, which is an amino acid found naturally in many foods. Normally, phenylalanine metabolism is controlled by the enzyme phenylalanine hydroxylase. In PKU patients, this enzyme does not function properly. That causes high blood levels of phenylalanine, which can lead to mental retardation, behavioral abnormalities, seizures and other neurological complications.

Kuvan increases the activity of phenylalanine hydroxylase in those PKU patients who have some residual functioning of this enzyme. This leads to improved breakdown and lower blood levels of phenylalanine. Still, in order for the drug to be most effective, patients on Kuvan must be on a phenylalanine-restricted diet, and blood levels must be monitored frequently.

The safety and efficacy of Kuvan was demonstrated in four short-term studies of 579 PKU patients. In addition, the manufacturer will establish general disease registries for PKU to help track clinical results and monitor any adverse effects.

Additional Information:

FDA Press Release. FDA Approves Kuvan for Treatment of Phenylketonuria (PKU). December 13, 2007.
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01761.html

tag: Drug Approval, FDA, PKU, Phenylketonuria, BioMarin Pharmaceutical, Merck, Kuvan, sapropterin dihydrochloride, phenylalanine,

Severe Bone, Joint, or Muscle Pain With Osteoporosis Drugs

FDA is alerting healthcare professionals that severe bone, joint, or muscle pain can occur in patients taking bisphosphonate drugs such as Fosamax (alendronate sodium), Actonel (risedronate sodium), Reclast (zoledronic acid) and Boniva (ibandronate sodium). These drugs are used to treat osteoporosis and certain other diseases.

This severe, sometimes incapacitating musculoskeletal pain has occurred within days, months, or even years after starting bisphosphonates. In the most serious cases, the pain was so severe that patients could not continue their normal activities. Some patients have complete relief of symptoms after they stop taking the drug, while others have reported slow or incomplete resolution.

Note that these events are different from the acute phase response some patients experience after the first treatment with IV bisphosphonates, and occasionally after the first dose of oral bisphosphonates.

Although severe musculoskeletal pain is described in the labeling for all bisphosphonates, this association may be overlooked by practitioners because they may assume that the patient's pain can be attributed to osteoporosis itself.

Practitioners should consider whether musculoskeletal pain in patients on bisphosphonates might be caused by the drug, and consider discontinuing it either temporarily or permanently.

Additional Information:

FDA MedWatch Safety Alert. Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa). January 7, 2007.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Bisphosphonates
http://www.fda.gov/cder/drug/infopage/bisphosphonates/default.htm

tag: FDA Advisory, Drug Safety, musculoskeletal pain, Bisphosphonates, Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, Zometa,

FDA Seeks $2.2 Million Penalties From Advanced Bionics, LLC and its president and co-CEO, Jeffrey H. Greiner.

FDA Seeks Civil Penalties from Calif. Device Maker

The U.S. Food and Drug Administration (FDA) today announced it is seeking a $2.2 million penalty against a California hearing aid manufacturer for violations of federal law, including manufacturing standards violations and the failure to notify the FDA of a change in an outside supplier or vendor, which may have exposed recipients of the devices to unnecessary health risks.

The hearing aids pose a public health risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss.

The agency's complaint, originally filed this past November and amended on March 17, seeks penalties against California medical device manufacturer Advanced Bionics, LLC and its president and co-CEO, Jeffrey H. Greiner.

The complaint alleges that Advanced Bionics shipped hearing aids to customers in the United States prior to filing appropriate supplemental information with the Agency, including a notice of changes made to the devices that affected their safety and effectiveness.

On July 7, 2003, Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Stimulator, a cochlear implant hearing aid surgically implanted under the skin behind the ear to treat profound hearing loss in adults and children. The hearing aid is considered a Class III device by the FDA—the most stringent regulatory category for devices.

The complaint alleges that the company failed to comply with the FDA's current Good Manufacturing Practice (GMP) requirements for devices. GMP requires that companies manufacturing medical devices for sale in the United States establish and follow quality systems procedures to assure the safety and quality of their products.

Advanced Bionic's alleged GMP violations include the failure to sufficiently evaluate and select a new vendor as the supplier of a critical device component and the failure to adequately validate the continued safety and effectiveness of the hearing aid by testing lots under actual or simulated use when the unapproved vendor's component was used.

The complaint also states that Advanced Bionics shipped hearing aids in violation of the law between January 2005 and July 2006. Two hearing aids shipped and implanted after a March 2006 recall contained the component from the unapproved vendor.

FDA's complaint states that the company's failure to file the required supplement occurred after a 2001 inspection. At that time, the company was cited for similar failures and made commitments to correct the problems.

Advanced Bionics, LLC, is located in Sylmar, Calif.

tag: FDA Action, Advanced Bionics, FDA Penalties, HiRes90k Implantable Cochlear Stimulator, hearing aid manufacturing standards violations, Good Manufacturing Practice,

Public Health Alert for Frozen, Stuffed Raw Chicken Products

WASHINGTON, March 29, 2008 - The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) is issuing a public health alert due to illnesses from Salmonella associated with frozen, stuffed raw chicken products that may be contaminated with Salmonella.
FSIS is reminding consumers of the crucial importance of following package instructions for frozen, stuffed raw chicken products and general food safety guidelines when handling and preparing any raw meat or poultry. It is especially important that these products be cooked in a conventional oven.

All poultry products should be cooked to a safe minimum internal temperature of 165° Fahrenheit as determined by a food thermometer. Using a food thermometer is the only way to know that food has reached a high enough temperature to destroy foodborne bacteria.

Frozen raw chicken breast products covered by this alert and similar products, may be stuffed or filled, breaded or browned such that they appear to be cooked. These items may be labeled "chicken cordon bleu," "chicken kiev" or chicken breast stuffed with cheese, vegetables or other items.

This public health alert was initiated after an investigation and testing conducted by the Minnesota Department of Health and Minnesota Department of Agriculture determined that there is an association between the products listed below and 2 illnesses. The illnesses were linked through the epidemiological investigation by their PFGE pattern (DNA fingerprint).

Products linked to the illnesses were produced by Serenade Foods, a Milford, Ind., establishment. Products include "Chicken Breast with Rib Meat Chicken Cordon Bleu" and "Chicken Breast with Rib Meat Buffalo Style" sold under the brand names "Milford Valley Farms," "Dutch Farms" and "Kirkwood." The individually wrapped, 6-ounce products were produced on January 21, 2008 (date code C8021 is printed on the side of the package).

Each of these packages bears the establishment number "Est. P-2375" inside the USDA mark of inspection. These specific products were distributed to retail establishments in Illinois, Indiana, Minnesota, North Dakota, Vermont and Wisconsin.

Consumption of food contaminated with Salmonella can cause salmonellosis, one of the most common bacterial foodborne illnesses. Salmonella infections can be life-threatening, especially to those with weak immune systems, such as infants, the elderly and persons with HIV infection or undergoing chemotherapy. The most common manifestations of salmonellosis are diarrhea, abdominal cramps, and fever within eight to 72 hours. Additional symptoms may be chills, headache, nausea and vomiting that can last up to seven days.

Consumers with food safety questions can "Ask Karen," the FSIS virtual representative available 24 hours a day at AskKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day.
tag: FSIS Warning, USDA, Public Health Alert, Salmonella, foodborne bacteria, chicken cordon bleu, chicken kiev, PFGE pattern, DNA fingerprint, salmonellosis,

Nanodays 2008, From The Nanoscale Informal Science Education Network.

Nanodays 2008, the inaugural year in underway now and giving away very valuable information. (The Nanoscale Informal Science Education Network (NISE Net) is a national community of researchers and informal science educators dedicated to fostering public awareness, engagement, and understanding of nanoscale science, engineering, and technology.)
NanoDays was created to provide a time and way to get community-based educational outreach efforts focused on nanoscale science, technology and engineering. Partners participating in NanoDays create outreach events unique to their local communities and then provide feedback to the Network on their NanoDays experience. Initially expected to be a small rollout, NanoDays kits have now been distributed to 100 institutions across the country. The kits include a planning guide, marketing materials, background information and the materials necessary to do six different nano-based programs.

And interest continues to grow! While the physical kits have been distributed, partners that would also like to participate in NanoDays are invited to download all or some of the digital version of the NanoDays kit.

tag: NanoTechnology, Nanodays 2008, NISE Net, nanoscale science, NanoDays kits

siRNA Anticancer Therapy Advances With The Help From Nanoparticles

Nanotech News March 2008

Anticancer siRNA Therapy Advances, Thanks to Nanoparticles

Small pieces of nucleic acid, known as siRNAs (short interfering RNAs), can turn off the production of specific proteins, a property that makes them one of the more promising new classes of anticancer drugs in development. Indeed, at least two siRNA-based anticancer therapies, both delivered to tumors in nanoparticles, have begun human clinical trials. Now, three new reports highlight the progress that researchers are making in developing broadly applicable, nanoparticle-enabled siRNA anticancer therapeutics.

In the first report, Mark E. Davis, Ph.D., an investigator in the Nanosystems Biology Cancer Center at the California Institute of Technology, and former graduate student Derek Bartlett, Ph.D., now at the City of Hope, used mathematical modeling and results from dosing experiments in a mouse model of human cancer to explain therapeutic response with various dosing regimes for both targeted and untargeted siRNA-containing nanoparticles. The results of this work, published in the journal Biotechnology and Bioengineering, provide guidelines for optimizing the design of siRNA-based anticancer therapies.

In their experiments, the investigators used a cyclodextrin-based nanoparticle to deliver an siRNA agent designed to reduce production of ribonucleotide reductase subunit M2 (RRM2), which plays an important role in tumor growth. The investigators created two versions of their nanoparticle formulation, one targeted to transferrin, a protein overexpressed by many tumors, and the other untargeted. They also used two different dosing regimens, one consisting of three consecutive daily injections, the other consisting of three injections spaced 3 days apart.

Data from these experiments showed that targeted nanoparticles were far more effective than untargeted nanoparticles at reducing tumor growth. Dosing regimen, however, had no statistically significant impact on the outcome for either nanoparticle formulation. Closer examination of tumors removed from the animals following treatment showed that the targeted nanoparticles were able to deliver siRNA into the tumors, although the final distribution of siRNA throughout the tumors was not uniform. The investigators then modeled the observed responses; the results of these simulations led them to conclude that it is not necessary to persistently shut down protein production in order to achieve a therapeutic response using siRNA. Instead, they concluded, it is more important to maximize the number of cells reached with a sufficient dose of siRNA agent.

In a second report, Leaf Huang, Ph.D., and his colleagues at The University of North Carolina at Chapel Hill, describe their development of a self-assembling siRNA-liposomal formulation that they can then coat with poly(ethylene glycol) (PEG) linked to a targeting agent. This targeted liposome was fourfold more effective than an untargeted, but otherwise identical, liposome at delivering siRNA into tumors. Gene silencing activity was also higher for the targeted version, with the therapeutic effect lasting 4 days. The investigators also found that although the targeted nanoparticle effectively penetrated lung metastases, it did not enter liver cells. In addition, the targeted nanoparticle showed little immunotoxicity. These results appear in the Journal of Controlled Release.

Another paper published in the same journal, this one from Stefaan De Smedt, Ph.D., and his collaborators at Ghent University in Belgium, describes a method that could prove useful in both preclinical and clinical studies of nanoparticle-enabled siRNA therapeutics. Their new technique uses fluorescence fluctuation spectroscopy to measure the stability of these formulations, even at low concentrations, in human serum in less than 1 minute. Serum stability of siRNA-containing nanoparticles is essential to therapeutic efficacy, given that most studies have shown that naked siRNA has little effect on tumors. Using this method, the investigators were able to show that even PEGylated siRNA-containing liposomes were releasing the bulk of their cargo in serum.

The work from Drs. Davis and Bartlett, supported by the NCI’s Alliance for Nanotechnology in Cancer, is detailed in the paper “Impact of tumor-specific targeting and dosing schedule on tumor growth inhibition after intravenous administration of siRNA-containing nanoparticles.” An abstract of this paper is available through PubMed.

View abstract

The work from Dr. Huang’s group is detailed in the paper “Efficient gene silencing in metastatic tumor by siRNA formulated in surface-modified nanoparticles.” An investigator from Hokkaido Pharmaceutical University also participated in this study. An abstract of this paper is available through PubMed.

View abstract

The work from Dr. De Smedt and colleagues is detailed in the paper “A fast and sensitive method for measuring the integrity of siRNA-carrier complexes in full human serum.” Investigators from the University of Leuven (Belgium) also participated in this study. An abstract of this paper is available through PubMed.

View abstract

tag: Cancer, Nanoparticles, Anticancer, siRNA, short interfering RNAs, journal Biotechnology and Bioengineering, transferrin, ribonucleotide, PubMed, Cancer Research

At Home DNA Paternity Testing, (Tell Me Who Is Your Daddy!)

From eminent doctors to bloggers like me are ranting and raving about Paternity Test Collection Kit. The kit and a test cost $148.99. The kit can be purchased from a retailer for $29.99 and the test require a lab fee of $119. There are other kits available for different needs like privately double checking your wife!. But bigger problem it seems where to shelve them at the store? next to condoms or pregnancy test kits.
This is not much different from the DNA ancestry test many of us have done except that this is comparing two or three individuals to identify the Father of a child.
So what about this test? I have not tested it nor have I found anything to credit or discredit it. But I liked what Dr.Gupta wrote about it. Follow the link at bottom for Dr.Gupta's view on it.

SALT LAKE CITY (March 25, 2008) - Identigene, an industry leader in DNA identification testing, today announced that its Identigene DNA Paternity Test Collection Kit is now available for over-the-counter purchase at all Rite Aid drug stores throughout the U.S. with the exception of stores in New York state. The Identigene DNA Paternity Test Collection Kit was the first DNA test ever sold in retail stores when it was offered on a trial basis beginning November 2007 in California, Washington and Oregon. Demand has been very strong, store sales are brisk and Identigene has been inundated with questions regarding the product's availability.

"Over-the-counter sales offers a completely new marketing channel for DNA testing. It makes the process more convenient and affordable while ensuring reliability and confidentiality," said Doug Fogg, COO of Identigene. "We learned that people are extremely receptive to the idea of purchasing a DNA paternity test kit while shopping at one of the nations leading drug store chains." Outside New York state, Rite Aid has 4,363 stores in 30 states and the District of Columbia. Fogg said he anticipates the Identigene DNA Paternity Test Collection Kits will be sold in New York state at a later date.

In the past, to obtain a DNA paternity test often required involvement of doctors or lawyers, weeks of waiting for results and a cost of multiple hundreds of dollars. "Because of my personal circumstances, the day I left the hospital after my son was born I turned in case papers for a paternity test," said Natalie Maynes of Vancouver, Wash. "Two months went by with no word, so I called. They told me with their waiting list, test results could be up to six months away. That night on the news, I learned I could buy an Identigene DNA Paternity Test Collection Kit at Rite Aid. Taking samples was easy, and it was nice to be able to do it ourselves. Five days later, we had our results."

With an Identigene DNA Paternity Test Collection Kit, participants of the test collect a DNA sample by rubbing a swab inside their mouth. The samples, along with consent forms and a lab fee are sent in an enclosed postage-paid return envelope to Identigene for processing. Results are available from Identigene within three to five business days of receipt. Customers can choose to receive results by mail, email, or online through a secured Web service. All information remains strictly confidential.

Suggested retail price for an Identigene DNA Paternity Test Collection Kit is $29.99, and the laboratory processing fee is $119.
Dr.Gupta..

tag: Paternity Test, At Home Paternity Test, DNA Paternity Test Collection Kit, Rite Aid, pregnancy test, Identigene,

FDA Approves FreeStyle Navigator® Continuous Glucose Monitoring System

Product Name: FreeStyle Navigator® Continuous Glucose Monitoring System
PMA Applicant:Abbott Diabetes Care
Address: 1360 South Loop Road, Alameda, CA 94502
Approval Date: March 12, 2008
Approval Letter: http://www.fda.gov/cdrh/pdf5/p050020a.pdf

What is it? The FreeStyle Navigator Glucose Monitoring System is a glucose sensor that reports glucose values continuously for up to 120 hours. These readings are used with fingerstick results to detect trends and patterns in glucose levels in adults, age 18 and over, with diabetes.

How does it work? The sensor is inserted in either the abdomen or the back of the upper arm. After a 10 hour start-up period, the FreeStyle Navigator Continuous Glucose Monitoring System is calibrated with a fingerstick measurement taken by a built-in glucose meter. After calibration, the FreeStyle Navigator System provides continuous glucose readings and updated glucose trend information for viewing. The FreeStyle Navigator Continuous Glucose Monitoring System also contains a built-in alarm that can be programmed to alert the user when results fall below pre-set low and pre-set high levels, and another alarm to alert users before their results reach pre-set levels.

When is it used? The FreeStyle Navigator Continuous Glucose Monitoring System is used with fingerstick measurements to provide additional glucose information to adults with diabetes, age 18 and over, and their healthcare practitioners. The Indications for Use are:

The FreeStyle Navigator Continuous Glucose Monitoring System is indicated for continually recording interstitial fluid glucose levels in people (ages 18 and older) with diabetes mellitus for the purpose of improving diabetes management. Readings and alarms about glucose levels from the FreeStyle Navigator Continuous Glucose Monitoring System are not intended to replace traditional blood glucose monitoring. Before adjusting therapy for diabetes management based on the results and alarms from the FreeStyle Navigator Continuous Glucose Monitoring System, traditional blood glucose tests must be performed. The FreeStyle Navigator Continuous Glucose Monitoring System provides a built-in blood glucose meter to confirm the continuous glucose result.

The FreeStyle Navigator Continuous Glucose Monitoring System provides real-time readings, graphs, trends and glucose alarms directly to the user. The FreeStyle Navigator Continuous Glucose Monitoring System is intended to be used in home settings to aid people with diabetes in predicting and detecting episodes of hypoglycemia and hyperglycemia and in clinical settings to aid healthcare professionals in evaluating glucose control. The FreeStyle Navigator Continuous Glucose Monitoring System is available only by prescription.

What will it accomplish? Additional glucose information may help people with diabetes and their healthcare practitioners to better manage their disease by providing more information on glucose trends and patterns than can be obtained with fingerstick glucose measurements alone.

When should it not be used?

• Results from this device are not designed to replace blood glucose meter measurements.
• Treatment decisions should not be based solely on results from the FreeStyle Navigator Continuous Glucose Monitoring System. You must confirm with a blood glucose meter measurement before making therapeutic adjustments.
• Symptoms related to low or high blood glucose levels should not be ignored. If you have symptoms of low or high glucose, use your blood glucose meter to check the FreeStayle Navigator System results.

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf5/p050020.html

Diabetes Information:
http://www.nlm.nih.gov/medlineplus/diabetes.html

Interactive Tutorial on Diabetes (requires Flash plug-in): http://www.nlm.nih.gov/medlineplus/tutorials/diabetesintroduction/htm/index.htm

tag: FDA Approval, Medical Devices, FreeStyle Navigator® Continuous Glucose Monitoring System

Medication Errors Are Preventable

FDA 101: Medication Errors

A medication error is any preventable event that may cause or lead to inappropriate medication use or harm to a patient. Since 2000, the Food and Drug Administration (FDA) has received more than 95,000 reports of medication errors. FDA reviews reports that come to MedWatch, the agency's adverse event reporting program.

"These reports are voluntary, so the number of actual medication errors is believed to be higher," says Carol Holquist, R.Ph., Director of the Division of Medication Error Prevention in FDA's Center for Drug Evaluation and Research.

FDA works with many partners to track medication errors, including the U.S. Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP). "Every report received through the USP/ISMP Voluntary Medication Error Reporting Program (MERP) automatically gets sent to FDA's MedWatch program," says Mike Cohen, R.Ph., Sc.D., President of ISMP. "It takes a cooperative approach to monitor errors, evaluate them, and educate the public about strategies to keep errors from happening again."

Medication errors occur for a variety of reasons. For example, miscommunication of drug orders can involve poor handwriting, confusion between drugs with similar names, poor packaging design, and confusion of metric or other dosing units.

"Medication errors usually occur because of multiple, complex factors," says Holquist. "All parts of the health care system—including health professionals and patients—have a role to play in preventing medication errors."

FDA's Role

• Drug Name Review:
  To minimize drug name confusion, FDA reviews about 400 drug names a year that companies submit as proposed brand names. The agency rejects about one-third of the names that drug companies propose.
• Drug Labels:
  FDA regulations require all over-the-counter (OTC) drug products (more than 100,000) to have a standardized "drug facts label." FDA has also improved prescription drug package inserts for health care professionals.
• Drug Labeling and Packaging:
  FDA works with drug companies to reduce the risk of errors that may result from similar-looking labeling and packaging, or from poor product design.
• Bar Code Label Rule:
  In accordance with an FDA rule that went into effect in 2004, bar codes are required on product labels for certain drugs and biologics such as blood. When used with bar code scanner and computerized patient information systems, bar code technology can help ensure that the right dose of the right drug is given to the right patient at the right time.
• Error Analyses:
  FDA reviews about 1,400 reports of medication errors per month and analyzes them to determine the cause and type of error.
• Guidances for Industry:
  FDA is working on three new guidances—one on complete submission requirements for anaylsis of trade names, one about the pitfalls of drug labeling, and another on best test practices for naming drugs.
• Public Education:
  FDA spreads the message about medication error prevention through public health advisories, medication guides, and outreach partnerships with other organizations.

Examples of Medication Errors

Misuse of Tussionex Prescription Cough Medicine:
On March 11, 2008, FDA informed health care professionals about adverse events and deaths in children and adults who have taken Tussionex Pennkinetic Extended-Release Suspension (Tussionex). Tussionex is a long-acting prescription cough medicine.

Hydrocodone, the narcotic ingredient in this medicine that controls cough, can cause life-threatening breathing problems when too much medicine is given at one time or when the medicine is given more frequently than recommended. Tussionex should not be used in children less than 6 years old.

Reports indicate that health care professionals have prescribed Tussionex for patients younger than the approved aged group of 6 years old and older, more frequently than the labeled dosing interval of every 12 hours ("extended release"), and that patients have administered the incorrect dose due to misinterpretation of the dosing directions and the use of inappropriate measuring devices. Overdose of Tussionex in older children, adolescents, and adults has also been associated with life-threatening and fatal breathing problems.

For more information, see FDA Issues Alert on Tussionex at www.fda.gov/bbs/topics/NEWS/2008/NEW01805.html

and the FDA Public Health Advisory at www.fda.gov/cder/drug/advisory/hydrocodone.htm

Overdoses of Cough and Cold Products in Children:
Roughly 7,000 children ages 11 and younger are treated in hospital emergency rooms each year because of overdoses of OTC cough and cold medication, according to a recent study by the Centers for Disease Control and Prevention. About two-thirds of those incidents occurred when children took medication without a parent's knowledge. Parents should keep medication out of children's reach and should never describe medication as "candy."

OTC cough and cold products can be harmful if more than the recommended amount is used, if they are given too often, or if more than one product containing the same active ingredient is used. In January 2008, FDA issued a public health advisory recommending that OTC cough and cold products not be used in infants and children under 2.

Serious injuries and deaths have resulted from such errors as misunderstanding directions and failing to use the measuring devices that come with the medicine. For more information, see OTC Cough and Cold Products: Not for Infants and Children Under 2 Years of Age. www.fda.gov/consumer/updates/coughcold011708.html

Overdoses of Acetaminophen:
Taking too much of the pain reliever acetaminophen can lead to serious liver damage. The drug is sold under brand names such as Tylenol and Datril, and is also available in many cough and cold products, prescription pain relievers, and sleep aids.

To avoid accidental overdosing, consumers should not take more than the recommended dose on the label. Also, acetaminophen should not be taken for more days than recommended, and should not be taken with other drug products that also contain acetaminophen without direction from a health care provider.

Parents should be cautious when giving acetaminophen to children. For example, the infant drop formula is three times more concentrated than the children's liquid. So parents need to be sure to give the appropriate dose.

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Misuse of Fentanyl Patches:
FDA has issued warnings about the fentanyl transdermal system, an adhesive patch that delivers an opioid called fentanyl through the skin. An opioid is a potent pain medicine. It is also sometimes called a narcotic drug. Other examples of opioids include hydrocodone, morphine, and oxycodone.

The directions on the product label and package insert of the fentanyl transdermal system should be followed exactly in order to avoid overdose. Fentanyl patches should not be used for short-term acute pain, pain that is not constant, or for pain after an operation. The patch is only for moderate-to-severe chronic pain that is expected to last for any number of weeks or longer and that cannot be managed by acetaminophen-opioid combinations, nonsteroidal analgesics, or as-needed dosing with short-acting opioids.

Fentanyl patches are mostly prescribed for patients with cancer. Recent reports to FDA describe deaths and life-threatening side effects after doctors and other health care professionals inappropriately prescribed the patch to relieve pain after surgery, for headaches, or for occasional or mild pain in patients who were not opioid tolerant.

In other cases, patients have used the patch incorrectly. The patients replaced the patch more frequently than directed in the instructions, applied more patches than prescribed, or applied heat to the patch. All of these cases resulted in dangerously high fentanyl levels in the blood.

For more information, see FDA Issues Second Safety Warning on Fentanyl Skin Patch www.fda.gov/bbs/topics/NEWS/2007/NEW01762.html

FDA Public Health Advisory www.fda.gov/cder/drug/advisory/fentanyl_2007.htm

Overdoses with Methadone:
FDA has issued a public health advisory cautioning practitioners to avoid overdoses when they are prescribing methadone or managing patients taking the drug.

Since the 1970s, methadone has been primarily used in treating drug abuse, but it is increasingly being used to treat pain. FDA issued the advisory because of reports of life-threatening adverse events and death in patients receiving methadone for pain control. Like other opioids, methadone causes slowed breathing, affects heart rate, and can also interact with other drugs. An overdose can occur because methadone stays in the body longer than the pain relief lasts.

For more information, see FDA's Public Health Advisory on methadone www.fda.gov/cder/drug/advisory/methadone.htm

Mix-ups Between Edetate Disodium and Edetate Calcium Disodium:
Both edetate disodium and edetate calcium disodium work by binding with heavy metals or minerals in the body, allowing them to be passed out of the body through the urine. Edetate calcium disodium was approved to treat severe lead poisoning. Edetate disodium was approved as an emergency treatment for certain patients with very high levels of calcium in the blood or certain patients with heart rhythm problems resulting from high amounts of the medication digoxin in the blood.

But a number of uses that are not approved by FDA have emerged. These include the removal of other heavy metals from the blood and the treatment of heart disease, commonly referred to as "chelation therapies."

In January 2008, FDA issued a public health advisory, warning that some children and adults have died when they were mistakenly given edetate disodium instead of edetate calcium disodium (calcium disodium versenate), or when edetate disodium was used for chelation therapies and other uses not approved by FDA.

The drugs are easily mistaken for each other because they have very similar names and are both commonly referred to only as "EDTA." One of FDA's recommendations is that the abbreviation not be used.

For more information, see FDA's Public Health Advisory on Edetate Disodium (marketed as Endrate and generic products) www.fda.gov/cder/drug/advisory/edetate_disodium.htm

For More Information

6 Tips to Avoid Medication Mistakes
www.fda.gov/consumer/updates/medtips062107.html

Medication Errors (FDA)
www.fda.gov/cder/drug/MedErrors/default.htm

Reporting Adverse Experiences to FDA
www.fda.gov/medwatch/how.htm

Institute for Safe Medication Practices
www.ismp.org

U.S. Pharmacopeia
www.usp.org

tag: FDA Guidance, medication errors, Medication Error Prevention, Pharmacopeia, Safe Medication Practices, Tussionex Prescription Cough Medicine, Hydrocodone,

Toy Recall Rock ‘N Ride Plush Rocker Toys Recalled By Tek Nek Toys.

There is a bunch of recalls today including this.
Recallr: Rock ‘N Ride Plush Rocker Toys Recalled By Tek Nek Toys.
tag: cpsc recall, Toy Recall, Rock ‘N Ride Plush Rocker Toys Recall, Tek Nek Toys Recall

FDA Early Communication about an Ongoing Safety Review of Ziagen (Abacavir)

The FDA issued an Early Communication about recent findings of The Data Collection on Adverse Events of Anti-HIV Drugs Study. Data analyses from this study indicate a higher risk of heart attack in patients infected with HIV-1 who were taking Ziagen (abacavir) or Videx (didanosine) as part of their drug therapy. The study is a large observational study of 33,347 HIV-1 infected patients living in North America, Europe and Australia. Patients in this study are being followed to evaluate the short and long term adverse effects of treatment with anti-HIV drugs. FDA continues to evaluate the overall risks and benefits of abacavir and didanosine. This evaluation may result in the need to revise labeling for the products. Until the FDA’s review is complete, health care professionals should evaluate the potential risks and benefits of each HIV-1 antiretroviral drug their patients are taking.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.

Early Communication about an Ongoing Safety Review of Ziagen (Abacavir) and Videx (Didanosine)

This information reflects FDA's current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded a causal relationship exists between the drug products and the emerging safety issue. Nor does it mean that FDA is advising healthcare professionals to discontinue prescribing these products. FDA is considering, but has not reached a conclusion as to whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.

FDA has been made aware of recent findings from analyses of data collected from "The Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Study". The D:A:D Study is a large observational study of 33,347 HIV-1 infected patients living in North America, Europe and Australia. Patients in this study are being followed to evaluate the short- and long-term adverse effects of treatment with anti-HIV drugs.

Analyses of data collected through February 1, 2007 examined the risk of myocardial infarction (heart attack) in patients taking selected HIV drugs from the class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs): zidovudine, stavudine, abacavir, didanosine, and lamivudine. The analyses, specifically, describe the relative risk of heart attack among cumulative use, recent use (currently using or use within the past 6 months), and past use (last use greater than 6 months ago) of these drugs.

These analyses showed that recent use of abacavir or didanosine was associated with an increased risk of heart attack. Patients taking either of these drugs had a greater chance of developing a heart attack than patients taking other medications. The risk did not appear to increase over time, but remained stable and appeared to be reversible after abacavir or didanosine were stopped.

In late 2007, GlaxoSmithKline (GSK), the manufacturer of abacavir, received the preliminary findings from the D:A:D Study analyses and conducted a search of their own clinical study databases. The results of the GSK analysis are inconclusive, but did not show an increased risk. Bristol Myers Squibb (BMS), the manufacturer of didanosine, conducted an analysis of their clinical databases, and similarly, found no increased risk for heart attack with didanosine use. The results of the BMS analysis are also inconclusive.

Key findings from the D:A:D Study are as follows:

• The excess risk of heart attack in patients taking at least some NRTIs appears to be greater in patients with other risk factors for heart disease. Risk factors include a history of heart disease, high cholesterol, high blood pressure, diabetes, smoking, and age.
  
  
• Certain analyses found the risk of heart attack increased by 49% in patients taking didanosine and increased by 90% in patients taking abacavir.
  
  
• The increased risk for heart attack remained stable over the course of treatment and the effect was not seen 6 months after stopping the drugs.
  
  

FDA currently believes analyses conducted with D:A:D Study data are incomplete; no analyses were conducted evaluating the risk of heart attack when patients take tenofovir or emtricitabine, two other drugs in the class of NRTIs. However, FDA continues to evaluate the overall risks and benefits of abacavir and didanosine. This evaluation may result in the need to revise labeling for the products. Until this evaluation is complete, healthcare providers should evaluate the potential risks and benefits of each HIV-1 antiretroviral drug their patients are taking, including abacavir and didanosine.

This early communication is in keeping with FDA's commitment to inform the public about ongoing safety reviews of drugs. FDA will work with the manufacturers of abacavir and didanosine to fully evaluate the risks and benefits associated with the use of these products as part of an HIV treatment regimen. As soon as this process is complete, FDA will communicate the conclusions and recommendations to the public.

The FDA urges healthcare professionals to promptly report serious and unexpected adverse reactions associated with abacavir to the FDA MedWatch reporting program, as described below.

• online at www.fda.gov/medwatch/report.htm
• by returning the postage-paid FDA form 3500 (available in PDF format at www.fda.gov/medwatch/getforms.htm) to 5600 Fishers Lane, Rockville, MD 20852-9787
• faxing the form to 1-800-FDA-0178
• by phone at 1-800-332-1088

tag: Ziagen, Abacavir, Videx, Didanosine, FDA Advisory, abacavir, didanosine, Anti-HIV Drugs, myocardial infarction, zidovudine, stavudine, abacavir, didanosine, lamivudine, GlaxoSmithKline, didanosine,

FDA Communication about an Ongoing Safety Review Regranex (becaplermin)

The FDA is conducting a safety review based on study data suggesting there may be an increased risk of death from cancer in diabetic patients using Regranex (becaplermin) Gel, a skin product used to heal leg and foot ulcers. While the review is ongoing, the FDA recommends health care professionals discuss the potential risks and benefits of using Regranex with their patients.

This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.

Communication about an Ongoing Safety Review Regranex (becaplermin)

This information reflects FDA’s current analysis of available data concerning this drug. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug product and the emerging safety issue. Nor does it mean that FDA is advising healthcare professionals to discontinue prescribing this product. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.

FDA has received information regarding a study that was performed to investigate the possibility of an increased risk of cancer in patients with diabetes who applied the product Regranex (a topical medicine) directly to their foot and leg ulcers. This study was done using a health insurance plan database of patients with diabetes who were at least 19 years of age or older, with no history of cancer and either prescribed Regranex or not. In this study, among those who were prescribed Regranex three or more times, there was an increase in the number of patients who died as a result of cancer. There was not enough information to say whether there was an increase in the number of patients that developed new cancers.

At this time, FDA believes that there may be some evidence for an increased risk of death from cancer in patients who had repeated treatments with Regranex. Because there are known risks associated with diabetic foot and leg ulcers that do not heal, the potential risk of using Regranex should be weighed against the benefit for each individual patient.

What does FDA know now about these data?

Regranex is a medicine that is a recombinant form of human platelet-derived growth factor which is applied directly to diabetic foot and leg ulcers that are not healing. The recombinant form of platelet growth factor has a biologic activity that is much like that produced naturally by the body. Growth factors cause cells to divide more rapidly. It is for this reason that the manufacturer continued to monitor studies begun before Regranex was approved in December 1997 for any evidence of adverse effects such as increased numbers of cancers. In a long term safety study completed in 2001, there were more cancers in people who used Regranex than in those who did not use it.

Following the report of the study completed in 2001, an additional study was performed using a health insurance database that covered the period from January, 1998 through June, 2003. This study used the database to identify two groups of patients with similar diagnoses, drug use, and use of health services, one of which used Regranex and one group that did not. The results of this study showed that deaths from cancer were higher for patients who were given three or more prescriptions for treatment with Regranex than those who were not treated with Regranex. No single type of cancer was identified, but rather deaths from all types of cancer, combined were observed.

This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA will communicate our conclusions, resulting recommendations and any regulatory actions to the public after the review of the data are completed.

The FDA urges healthcare professionals to promptly report serious and unexpected adverse reactions associated with Regranex to the FDA MedWatch reporting program, as described below.

• online at www.fda.gov/medwatch/report.htm
• by returning the postage-paid FDA form 3500 (available in PDF format at www.fda.gov/medwatch/getforms.htm) to 5600 Fishers Lane, Rockville, MD 20852-9787
• faxing the form to 1-800-FDA-0178
• by phone at 1-800-332-1088

tag: FDA Advisory, Regranex, becaplermin, Ongoing Safety Review, healthcare, foot ulcers, leg ulcers, MedWatch

FDA Early Communication About Montelukast (Singulair)

Early Communication About an Ongoing Safety Review of Montelukast (Singulair)

This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug product and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing this product. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.

FDA is investigating a possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Singulair is a medicine in the drug class known as leukotriene receptor antagonists. Singulair is used to treat asthma and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose) and to prevent exercise-induced asthma.

Over the past year, the maker of Singulair, Merck & Co, Inc., has updated the prescribing information and patient information for Singulair to include the following post-marketing adverse events: tremor (March 2007), depression (April 2007), suicidality (suicidal thinking and behavior) (October 2007), and anxiousness (February 2008).

In February 2008, FDA and Merck discussed how best to communicate these labeling changes to prescribers and patients. Merck plans to highlight the recent changes in the prescribing information in face-to-face interactions with prescribers and provide prescribers with patient information leaflets about Singulair. The Singulair website includes the most current prescribing information and patient information for Singulair (www.singulair.com).

FDA is working with Merck to further evaluate a possible link between the use of Singulair and behavior/mood changes, suicidality and suicide in response to inquiries received by FDA. FDA has requested that Merck evaluate Singulair study data for more information about suicidality and suicide. FDA is reviewing the postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Singulair.

Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.

Singulair is an effective medicine that is indicated for the treatment of asthma and symptoms of allergic rhinitis. Patients should not stop taking Singulair before talking to their doctor if they have questions about this new information. Until further information is available, healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood.

Other leukotriene modifying medications include zafirlukast (Accolate), which is also a leukotriene receptor antagonist and zileuton (Zyflo and Zyflo CR), which is a leukotriene synthesis inhibitor. FDA is reviewing postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Accolate, Zyflo, and Zyflo CR and will assess whether further investigation is warranted.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.

The FDA urges both healthcare professionals and patients to report side effects from the use of Singulair, Accolate, Zyflo, and Zyflo CR to the FDA's MedWatch Adverse Event Reporting program

• on-line at [www.fda.gov/medwatch/report.htm];
• by returning the postage-paid FDA form 3500 [available in PDF format at [www.fda.gov/medwatch/getforms.htm] to 5600 Fishers Lane, Rockville, MD 20852-9787;
• faxing the form to 1-800-FDA-0178; or
• by phone at 1-800-332-1088

tag: FDA Action, Singulair, suicidality, Montelukast, Merck & Co, tremor, depression, anxiousness, leukotriene, zafirlukast, Accolate, zileuton, Accolate, Zyflo, Zyflo CR

FDA Warning On "Total Body Formula" and "Total Body Mega Formula"

FOR IMMEDIATE RELEASE March 27, 2008

Media Inquiries: Stephanie Kwisnek, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Warns Consumers about "Total Body Formula" and "Total Body Mega Formula"
Distributor recalls dietary supplement products after reports of adverse reactions

The U.S. Food and Drug Administration is advising consumers not to purchase or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.

The Total Body Formula products are sold in eight-ounce and 32-ounce plastic bottles. The Total Body Mega Formula is sold in 32-ounce plastic bottles. Both products are distributed by Total Body Essential Nutrition of Atlanta. The company is the sole distributor of the products and has voluntarily recalled Total Body Formula in the flavors of Tropical Orange and Peach Nectar and Total Body Mega Formula in Orange/Tangerine flavor.

The Florida Department of Health recently provided reports to the FDA on 23 individuals who experienced serious reactions to these products seven to 10 days after ingestion. In all cases, the reactions included significant hair loss, muscle cramps, diarrhea, joint pain and fatigue. The FDA subsequently learned and is investigating a report that some individuals in Tennessee using the same products have experienced similar reactions.

FDA laboratories are analyzing samples of the products to identify the cause of the reactions, including the possibility that the products contain excessive amounts of selenium, which is known to cause symptoms such as those described in the adverse events reported to the agency. Selenium, a trace mineral, is needed only in small amounts for good health.

The products have been distributed in Alabama, California, Florida, Georgia, Kentucky, Louisiana, Michigan, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia.

The FDA is advising consumers in all states to avoid using the products immediately and to discard the products by placing them in a trash receptacle outside of the home.

Consumers who have been taking the products and have experienced adverse reactions should consult their health care professional. Consumers and health care professionals can also report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.

The FDA is working with the Florida Department of Health in its investigation.

For more information, consumers can call the FDA's toll-free Food Safety Hotline at 1-888-SAFEFOOD.

tag: FDA Advisory, Total Body Formula, Total Body Mega Formula, significant hair loss, muscle cramps, diarrhea, joint pain, fatigue, Total Body Essential Nutrition of Atlanta, Selenium,

Why Food Labels Matter?

Click On The Image Above To Download A PDF version Of This Document

Consumers often compare prices of food items in the grocery store to choose the best value for their money. But comparing items using the food label can help them choose the best value for their health.

The food label identifies a variety of information about a product, such as the ingredients, net weight, and nutrition facts.

"The food label is one of the most valuable tools consumers have," says Barbara Schneeman, Ph.D., Director of the Food and Drug Administration's (FDA's) Office of Nutrition, Labeling and Dietary Supplements. "The food label gives consumers the power to compare foods quickly and easily so they can judge for themselves which products best fit their dietary needs."

For example, someone with high blood pressure who needs to watch salt (sodium) intake may be faced with five different types of tomato soup on the shelf, says Schneeman. You can quickly and easily compare the sodium content of each product by looking at the part of the label that lists nutrition information (Nutrition Facts Label) to choose the one with the lowest sodium content.

FDA regulations require nutrition information to appear on most foods, and any claims on food products must be truthful and not misleading. In addition, "low sodium," "reduced fat," and "high fiber" must meet strict government definitions. FDA has defined other terms used to describe the content of a nutrient, such as "low," "reduced," "high," "free," "lean," "extra lean," "good source," "less," "light," and "more." So a consumer who wants to reduce sodium intake can be assured that the manufacturer of a product claiming to be "low sodium" or "reduced in sodium" has met these definitions.

But you don't have to memorize the definitions. Just look at the Nutrition Facts Label to compare the claims of different products with similar serving sizes.

Nutrient Highs and Lows

Most nutrients must be declared on the Nutrition Facts Label as "percent Daily Value" (%DV), which tells the percent of the recommended daily intake in a serving of that product and helps the consumer create a balanced diet. The %DV allows you to see at a glance if a product has a high or low amount of a nutrient. The rule of thumb is 20% DV or more is high and 5% DV or less is low.

Health experts recommend keeping your intake of saturated fat, trans fat, and cholesterol as low as possible because these nutrients may increase your risk for heart disease. This is where the %DV on the Nutrition Facts Label can be helpful, says Schneeman. There is no %DV for trans fat, but you can use the label to find out whether the saturated fat and cholesterol are high or low, she says. When comparing products, look at the total amount of saturated fat plus trans fat to find the one lowest in both of these types of fat.

For beneficial nutrients, like fiber or calcium, you can use the %DV to choose products that contain higher amounts. Research has shown that eating a diet rich in fiber may lower your chances of getting heart disease and some types of cancer. And eating foods containing calcium may help lower your risk of getting the bone-weakening disease, osteoporosis.

Confusing Claims

The terms "natural," "healthy," and "organic" often cause confusion. "Consumers seem to think that 'natural' and 'organic' imply 'healthy,'" says Schneeman. "But these terms have different meanings from a regulatory point of view."

According to FDA policy, "natural" means the product does not contain synthetic or artificial ingredients. "Healthy," which is defined by regulation, means the product must meet certain criteria that limit the amounts of fat, saturated fat, cholesterol, and sodium, and require specific minimum amounts of vitamins, minerals, or other beneficial nutrients.

Food labeled "organic" must meet the standards set by the Department of Agriculture (USDA). Organic food differs from conventionally produced food in the way it is grown or produced. But USDA makes no claims that organically produced food is safer or more nutritious than conventionally produced food.

For example, says Schneeman, "A premium ice cream could be 'natural' or 'organic' and still be high in fat or saturated fat, so would not meet the criteria for 'healthy.'"

Ask and You May Receive

Most packaged foods are required by law to carry nutrition labeling. This labeling is voluntary for many raw foods, such as fruits, vegetables, and fish. FDA encourages stores that sell raw foods to display or distribute, near these foods, nutrition information to shoppers. To make it easy for retailers, FDA has created colorful posters that can be downloaded and printed from its Web site. The posters show nutrition information for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States.

"If the nutrition information is not displayed for these raw foods, we want consumers to ask, 'where's the nutrition information on your fresh products?'" says Camille Brewer, Deputy Director of FDA's Office of Nutrition, Labeling and Dietary Supplements. Industry responds to consumer demand, says Brewer. "Industry tells us all the time, 'if consumers ask, we'll give it to them.'"

FDA also encourages consumers to request nutrition information in full-service or fast-food restaurants. This information would help consumers make healthier choices outside the home, where Americans now spend nearly half of their total food budget, according to the National Restaurant Association and USDA's Economic Research Service.

Providing nutrition information for restaurant food is voluntary unless a nutrient content claim or a health claim is made for a menu item or meal. A nutrient content claim might be "low in fat," and a health claim might be "heart healthy." If such claims are made, the restaurant is required to give customers the appropriate nutrition information for these items when requested. This information does not have to be on the menu or on a menu board that's clearly visible to the consumer. The restaurant has the option of offering this information in various ways, such as in a brochure.

Many food service establishments have nutrition information for their offerings and will provide the information on the Internet or to customers who request it.

For More Information

How to Understand and Use the Nutrition Facts Label
www.cfsan.fda.gov/~dms/foodlab.html

Nutrition Facts Label Brochure
www.cfsan.fda.gov/~acrobat/nutfacts.pdf

A Key to Choosing Healthful Foods (English and Spanish)
www.cfsan.fda.gov/~dms/fflabel.html

Make Your Calories Count
www.cfsan.fda.gov/~ear/hwm/labelman.html

Downloadable/Printable Posters on Nutrition Information for Raw Fruits, Vegetables, and Fish
www.cfsan.fda.gov/~dms/nutinfo.html

tag: Food Labels, food safety, nutrition facts, Dietary Supplements, low sodium, reduced fat, high fiber, percent Daily Value, %DV, healthier choice,

FDA identifies 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy.

FOR IMMEDIATE RELEASE March 27, 2008

Media Inquiries: Chris DiFrancesco, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Identifies First Steps in Requirements for Safety Plans for Certain Drugs and Biologics
New FDAAA requirements being implemented

The U.S. Food and Drug Administration has identified 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy (REMS), the FDA said in a Federal Register notice published today.

Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), FDA can require manufacturers to submit a REMS when a drug first comes on the market, or later if FDA becomes aware of new safety data about the drug. The manufacturers of the 25 drugs and biologic products identified in today's notice must submit to the agency a proposed REMS by Sept. 21, 2008.

Certain drugs present a dilemma: They can provide an important benefit to patients, but they can be especially dangerous if not used properly. For example, certain drugs may be safe and effective for patients, but if taken while pregnant can harm the fetus or cause miscarriage. Rather than deny FDA approval of such drugs, the agency has granted approval and required that the manufacturer develop a safety plan, or REMS, to help ensure that health care professionals prescribe the drug correctly and that patients use it safely. While FDA has previously approved some drugs and biologics with these safety plans, the new law makes explicit FDA's authority to require them and contains specific enforcement authority when violations or noncompliance with the plan's requirements occur.

"These safety plans allow patients to have continued access to certain medicines for which there are safety concerns that can be managed through appropriate use," said Jane Axelrad, associate director for policy, Center for Drug Evaluation and Research, FDA. "The FDA approved the drugs identified today before the new law was passed, and they will now be brought under the new statutory authority to require and enforce REMS."

In addition to issuing this Federal Register notice about drugs approved before March 25, 2008, the FDA also is implementing the new authority for drugs that will be approved after March 25, 2008, as well as for already marketed drugs for which new risks are identified after March 25.

The FDA also advised the public to notify the agency if they believe other drugs should be considered to have REMS under the new statutory provisions.

The Federal Register notice, which includes a list of the 25 drugs and biologic products that will be required to submit REMS, is available at www.fda.gov/OHRMS/DOCKETS/98fr/E8-6201.htm.

tag: FDA Action, Risk Evaluation and Mitigation Strategy, REMS, Food and Drug Administration Amendments Act of 2007, FDAAA,

Midwest Residents Are Warned of Deadly Hazards that Arise After the Flood Waters Recede.

FOR IMMEDIATE RELEASE March 26, 2008 Release #08-232

CPSC Recall Hotline: (800) 638-2772 CPSC Media Contact: (301) 504-7908

Surviving the Aftermath of the Storm
Midwest Residents Are Warned of Deadly Hazards that Arise After the Flood Waters Recede

WASHINGTON, D.C. – As flood waters begin to recede and residents return home, the U.S. Consumer Product Safety Commission (CPSC) issues a warning to those affected by the floods in the Midwest. When there’s a power outage, NEVER use portable generators inside the home, in an attached garage or in any other partially enclosed space. Generator exhaust contains high levels of colorless, odorless carbon monoxide (CO) which can kill in minutes.

334 people died from generator-related CO poisoning from 1999-2006. Recent data show that as use of generators has increased, so too have deaths – tragically there are about 50 per year. Many of these deaths occurred after major storms knocked out power.

The Commission provides these important life-saving tips:

Generator Safety

• Never use a portable generator indoors – including open garages, basements, crawlspaces and sheds. Opening doors and windows or using fans will not prevent CO buildup in the home.
• During use, keep portable generators outdoors and far away from open doors, windows and vents, so that CO does not build up indoors.
• If you start to feel sick, dizzy or weak while using a generator, get to fresh air right away. Exposure to CO from generators can quickly lead to incapacitation and death.
• Keep generators dry. Wait for the rain to pass before using a generator. Consumer-grade generators are not weatherproof and can pose the risk of electrocution and shock when used in wet conditions.
• Do not connect the generator directly into your home's electrical system through a receptacle outlet – this is an extremely dangerous practice that poses a fire hazard and an electrocution hazard to utility workers and neighbors served by the same transformer.
• If using a generator, plug individual appliances into heavy duty, outdoor-rated extension cords and plug cords into the generator.

Other Precautions

• Check that the extension cords have a wire gauge adequate for the appliance loads and have all three prongs, including a grounding pin.
• Keep charcoal grills outside. Never use them indoors. Burning charcoal in an enclosed space can produce lethal levels of carbon monoxide.
• Make sure the batteries in your smoke alarm and carbon monoxide alarm are fresh. Test these alarms to make sure they are working.
• Exercise caution when using candles. Use flashlights instead. If you must use candles, do not burn them on or near anything that can catch fire. Keep burning candles away from drafts. Never leave burning candles unattended. Extinguish candles when leaving the room.

Wet Carpets and Furniture Are Dangerous to your Health

• Microorganisms may grow in these water-damaged products and may cause allergic reactions and infections. For more information, go to www.cpsc.gov/cpscpub/pubs/425.html
• Discard mattresses, wicker furniture, straw baskets and the like that have been water damaged. These cannot be recovered by washing or cleaning procedures.
• Throw out wet room-size carpets, drapes, upholstered furniture, stuffed toys, ceiling tiles and anything that can't be picked up and cleaned by dry cleaning, steam cleaning or put in a washing machine or dryer.
• Remove and replace wet insulation.

Avoid Electrical and Gas Hazards

• Look for signs that your appliances have gotten wet. Discard electrical or gas appliances that have been wet because they pose electric shock and fire hazards.
• Before using your appliances, have a professional or your gas or electric company evaluate your home and replace all gas control valves, circuit breakers, and fuses that have been under water.

Dangers to Children

• Medicines and chemicals should be thrown away. Water may have infected the integrity of the medicine. The U.S. Department of Health and Human Services offers additional safety tips. For more information, go to www.hhs.gov/news/broadcast/2005/CrawfordMedicationSafety.html
• Young children and water don't mix. Watch children around buckets, tubs and standing water in and around the home. Even small amounts of water can be a drowning hazard.

tag: CPSC News, odorless carbon monoxide, Wet Carpets, water-damaged product, Flood Advisory

All About Diary Products, Are You Lactose Intolerant?

The National Digestive Diseases Information Clearinghouse has issued the following information on Lactose Intolerance. I received the information via FDA and was very informative. I do love milk and certain milk gives me similar reactions to Lactose Intolerance but I continue to drink milk without any problems.

The complete text is also available as an Adobe Acrobat PDF file through this link. Or click on the picture below. Perhaps you know who is Lactose Intolerant and may be pass the information to them.

On this page:

• Intolerance is Not Allergy
• Symptoms
• Who Becomes Lactose Intolerant?
• Managing Lactose Intolerance
• Look at Labels
• Testing for Lactose Intolerance
• Tips for Consumers
• Raw Milk and Lactose Intolerance

Does your stomach churn after you drink milk? Do you have diarrhea soon afterward? If so, you may be lactose intolerant.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) estimates that 30 to 50 million Americans are lactose intolerant.

Being lactose intolerant means you can't digest lactose—the natural sugar found in milk and other dairy products. People who cannot digest lactose have a shortage, or deficiency, of an enzyme called lactase, which is produced in the small intestine. Lactase breaks down milk sugar into two simpler forms of sugar, which are then absorbed into the bloodstream.

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Intolerance is Not Allergy

Lactose intolerance is not the same as a milk allergy, says Kavita Dada, Pharm.D., a senior health promotion officer in the Food and Drug Administration's (FDA's) Division of Drug Information. "For most people with lactase deficiency, it's a discomfort."

But a food allergy—an abnormal response to a food triggered by the immune system—can be life-threatening. People with food allergies must avoid certain foods altogether. People with food intolerances can often eat small amounts of the offending foods without having symptoms.

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Symptoms

When there is not enough lactase to digest the lactose in the foods a person eats or drinks, the person may have

• gas
• stomach cramps
• bloating
• nausea
• diarrhea

These symptoms occur within 30 minutes to two hours after consuming food containing lactose. Some illnesses can cause these same problems, but a health care professional can do tests to see if the problems are caused by lactose intolerance or by another condition.

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Who Becomes Lactose Intolerant?

Lactose intolerance is more common in some ethnic groups than others. NIDDK estimates that up to 75% of all adult African Americans and Native Americans and 90% of Asian Americans are lactose intolerant.

As people age, their bodies produce fewer lactase enzymes, so most people don't have symptoms until they are adults.

Most people inherit the condition from their parents. Lactose intolerance is not very common in children under two years of age, unless the child has a lactase deficiency because of an injury to the small intestine. If you think your infant or child may be lactose intolerant, talk to your child's pediatrician.

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Managing Lactose Intolerance

There is no treatment to make the body produce more lactase enzyme, but the symptoms of lactose intolerance can be controlled through diet.

Most older children and adults do not have to avoid lactose completely. People have different levels of tolerance to lactose. Some people might be able to have a tablespoon of milk in a cup of coffee with little or no discomfort. Others have reactions that are so bad they stop drinking milk entirely. Some people who cannot drink milk may be able to eat ice cream and yogurt—which have less lactose than milk—without symptoms. They may also be able to consume a lactose-containing product in smaller amounts at any one time.

Common foods with lactose are

• milks, including evaporated and condensed
• creams, including light, whipping, and sour
• ice creams
• sherbets
• yogurts
• some cheeses (including cottage cheese)
• butters

Lactose may also be added to some canned, frozen, boxed, and other prepared foods such as

• breads and other baked goods
• cereals
• mixes for cakes, cookies, pancakes, and biscuits
• instant potatoes, soups, and breakfast drinks
• lunch meats (other than Kosher)
• frozen dinners
• salad dressings
• margarines
• candies and other snacks

Dietary supplements with lactase enzyme are available to help people digest foods that contain lactose. However, FDA has not formally evaluated the effectiveness of these products, and you may want to ask your doctor if these supplements are right for you.

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Look at Labels

"Lactose-free" or "lactose-reduced" milk and other products are widely available in grocery stores. These products may be fortified to provide the same nutrients as their lactose-containing counterparts.

There is no FDA definition for the terms "lactose free" or "lactose-reduced," but manufacturers must provide on their food labels information that is truthful and not misleading. This means a lactose-free product should not contain any lactose, and a lactose-reduced product should be one with a meaningful reduction. Therefore, the terms lactose-free and lactose-reduced have different meanings, and a lactose-reduced product may still contain lactose that could cause symptoms.

Lactose-free or lactose-reduced products do not protect a person who is allergic to dairy products from experiencing an allergic reaction. People with milk allergies are allergic to the milk protein, which remains when the lactose is removed.

Look at the ingredient label. If any of these words are listed, the product probably contains lactose:

• milk
• cream
• butter
• evaporated milk
• condensed milk
• dried milk
• powdered milk
• milk solids
• margarine
• cheese
• whey
• curds

Beware of foods labeled "non-dairy," such as powdered coffee creamers and whipped toppings. Some of these foods may contain an ingredient called caseinate, which comes from milk and contains lactose. Look for "caseinate" or "milk derivative" on the label if you are trying to avoid milk products.

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Testing for Lactose Intolerance

A doctor can usually determine if you are lactose intolerant by taking a medical history. In some cases, the doctor may perform tests to help confirm the diagnosis. A simple way to test at home is to exclude all lactose-containing products from your diet for two weeks to see if the symptoms go away, and then reintroduce them slowly. If the symptoms return, then you most likely are lactose intolerant. But you may still want to see your doctor to make sure that you are lactose intolerant and do not have a milk allergy or another digestive problem.

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Tips for Consumers

• If you are lactose intolerant, try lactose-free milk or dairy products lower in lactose, such as yogurt and cheese. You may be able to consume dairy products in small amounts without symptoms.
• Consume milk or other dairy products with other foods. This helps slow down digestion, making it easier for your body to absorb lactose.
• If you're eating few or no dairy products, ask your doctor or dietitian if you are getting enough calcium in your diet. You may need to take dietary supplements with calcium to keep your bones healthy.

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Raw Milk and Lactose Intolerance

FDA warns consumers not to drink raw, or unpasteurized, milk. "Raw milk advocates claim that pasteurized milk causes lactose intolerance," says John Sheehan, Director of FDA's Division of Plant and Dairy Food Safety. "This is simply not true. All milk, whether raw or pasteurized, contains lactose, and pasteurization does not change the concentration of lactose nor does it convert lactose from one form into another."

Raw milk advocates also claim that raw milk prevents or cures the symptoms of lactose intolerance. Arguing that raw milk contains Bifidobacteria, they claim these microorganisms are beneficial (probiotic) and create their own lactase, which helps people digest the milk.

"This is not true, either," says Sheehan. "Raw milk can contain Bifidobacteria, but when it does, the bacteria come from fecal matter (animal manure) and are not considered probiotic, but instead are regarded as contaminants."

Drinking raw milk will still cause uncomfortable symptoms in people who are correctly diagnosed as being lactose intolerant. But worse than this discomfort are the dangers of raw milk, which can harbor a host of disease-causing germs, says Sheehan. "These microorganisms can cause very serious, and sometimes even fatal, disease conditions in humans."

For More Information

Lactose Intolerance
http://digestive.niddk.nih.gov/ddiseases/pubs/lactoseintolerance/

Food Safety and Raw Milk
http://www.cfsan.fda.gov/~dms/rawm-toc.html

tag: FDA Services, Diary Product Information, Lactose Intolerance, Bifidobacteria, probiotic, Raw milk, lactase, non-dairy, lactose-reduced, lactose free, lactase enzymes, immune system

FDA Issues Recommendations And Draft Guidance on Medical Devices That Treat Blocked Heart Arteries, And Requests Public Comments.

FOR IMMEDIATE RELEASE March 26, 2008

Media Inquiries: Peper Long, 301-827-0599 Consumer Inquiries: 888-INFO-FDA

FDA Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries

U.S. Food and Drug Administration Commissioner Andrew C. von Eschenbach today announced that the agency has issued draft guidelines to aid the development, testing and manufacture of coronary drug-eluting stents, devices used to treat blocked heart arteries.

Over the past few years, FDA and the clinical community have been closely monitoring these devices, including concerns over clot formation in some patients several years after implantation. The draft guidelines issued today—called an FDA guidance document—outline the agency's recommendations for pre-market clinical evaluation and post-market studies, which may provide data to better address this and other potential safety concerns.

Each year in the United States, approximately one million patients undergo procedures to treat coronary atherosclerosis, also known as hardening or blockages of the heart arteries, a condition that can cause angina and heart attacks.

Some 650,000 of these patients are treated with drug-eluting stents, a scaffolding device that is placed into the arteries to prop them open. Drug-eluting stents have a coating that slowly releases a drug to prevent the growth of scar tissue that may accumulate after the initial procedure opens the artery. Re-accumulation of scar tissue can mean additional procedures to keep arteries open and preserve adequate blood flow.

"This draft guidance is part of FDA's ongoing effort to provide regulated industry with recommendations on measures that can minimize the risks while preserving for patients the benefits of drug-eluting stents," said Daniel G. Schultz, M.D., director of FDA's Center for Devices and Radiological Health.

This draft guidance, announced in today's Federal Register, http://www.gpoaccess.gov/fr/index.html, discusses the development pathway for new drug-eluting stents and provides recommendations on information necessary for a complete marketing submission. It also provides guidance on assessing the toxicity of the drug used to coat the stent, both on its own and as part of the complete product. Because these stents combine device and drug technology, this guidance contains expertise and input from two agency centers—the Center for Devices and Radiological Health and the Center for Drug Evaluation and Research.

Also included are draft recommendations for engineering tests, biocompatibility tests, and animal studies to assess the device's overall safety.

"This guidance demonstrates how FDA will need to work across traditional product boundaries to guide the development of innovative new products," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research.

Currently, FDA has approved three coronary drug-eluting stents.

A copy of the guidance, "Draft Guidance for Industry on Developing Coronary Drug Eluting Stents," can be found at http://www.fda.gov/cdrh/ode/guidance/6255.html.

FDA is planning a public workshop on drug-eluting stents, in part as one means of soliciting comments on this guidance. The date, location and method for comment for this workshop will be announced in the Federal Register and on FDA's Web site, www.fda.gov.

FDA invites public comment on this draft guidance for 120 days from today's publication in the Federal Register.

Typed comments should include the docket number (CD6255), and be sent to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

tag: FDA Guidance, FDA Recommendations, coronary drug-eluting stents, engineering tests, biocompatibility tests, CDER, Blocked Heart Arteries, medical Devices

Commissioner of the FDA, Gives You "Andy's Take", A Weekly Column

Commissioner of the Food and Drug Administration, Andy von Eschenbach will be will be giving us a weekly column called Andy' Take.

According to a post on the FDA site, the Commissioner will take on some of the events about food and medical products that you have been hearing about in the news or making the news.

In addition to the news we will hear about and learn about insights in to many initiatives that FDA is bringing forth to protect us.

The commissioner also wishes that you will add it to your bookmarks so that the FDA will continuously be your source for reliable information about food, medical products, and staying healthy.
I am a daily visitor to FDA site and I think if you care about yourself and the others around you, you also should visit. Perhaps reading Andy's Take might be a way to start!
Here is the link to first post and the podcast which you could download and listen on your iPod or any other MP3 player, including your computer.
tag: FDA News, Andy' Take, Commissioner of the Food and Drug Administration, Andy von Eschenbach

Do Not to Use “Blue Steel” and “Hero” Products, FDA Warns Consumers.

FOR IMMEDIATE RELEASE March 25, 2008

Media Inquiries: Stephanie Kwisnek, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Warns Consumers Not to Use “Blue Steel” and “Hero” Products
Products are illegal drugs and pose serious health risks

The U.S. Food and Drug Administration is advising consumers not to purchase or use "Blue Steel" or "Hero" products marketed as dietary supplements throughout the United States because they are considered unapproved drugs and have not been proven to be safe or effective. These products contain undeclared ingredients, which may dangerously affect a person’s blood pressure level.

These products are promoted and sold over the Internet for the treatment of erectile dysfunction (ED) and for sexual enhancement. They’re touted as “all natural” and labeled as dietary supplements. However, Blue Steel and Hero products do not qualify as dietary supplements because they contain undeclared and unapproved substances that are similar in chemical structure to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for ED.

"Because these products are labeled as ‘all natural dietary supplements,’ consumers may assume that they are harmless and pose no health risk,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “But an unsuspecting consumer with underlying medical issues may take these products without knowing that they can cause serious side effects and interact in dangerous ways with drugs that a consumer is already taking."

The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin), and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these medical conditions. Because they may have been advised against taking ED drugs, these men may seek products like Blue Steel and Hero because the products are marketed as "all natural" or as not containing the active ingredients in approved ED drugs.

FDA chemical analysis revealed that both Hero and Blue Steel contain substances that are similar in chemical structure to sildenafil; however, they are not components of an FDA approved drug. Additionally, the products’ label do not list any of these substances.

The FDA advises consumers who have used either of these products to discontinue use and consult their health care professional if they have experienced any adverse events that they feel are related to the use of these products. Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm. The FDA recommends that consumers should talk to their health care professional about FDA‑approved treatments for erectile dysfunction. The FDA may take further regulatory actions to protect consumers from these illegal products.

Blue Steel is sold in bottles containing 10 blue capsules or blister packs containing two blue capsules. Hero is sold in blister packs containing two blue capsules. Both products distributed by Active Nutraceuticals or the Marion Group, Carrollton, Ga.

For more information, visit: http://www.fda.gov/consumer/updates/erectiledysfunction010408.html

tag: fda warning, erectile dysfunction, sexual enhancement, Blue Steel, Hero, sildenafil, MedWatchActive Nutraceuticals, Marion Group,

FDA Asks To Avoid Fetal "Keepsake" Images, Heartbeat Monitors

While ultrasonic fetal scanning is generally considered a safe medical procedure, the use of it for unapproved and unintended purposes raises concerns.

The use of ultrasound imaging devices for producing fetal keepsake videos is viewed as an unapproved use by the Food and Drug Administration (FDA). Doppler ultrasound heartbeat monitors are not intended for over-the-counter (OTC) use. Both products are approved for use only with a prescription.

"Although there are no known risks of ultrasound imaging and heartbeat monitors, the radiation associated with them can produce effects on the body," says Robert Phillips, Ph.D., a physicist with FDA's Center for Devices and Radiological Health (CDRH). "When ultrasound enters the body, it heats the tissues slightly. In some cases, it can also produce small pockets of gas in body fluids or tissues."

Phillips says the long-term effects of tissue heating and of the formation of partial vacuums in a liquid by high-intensity sound waves (cavitation) are not known.

Using ultrasound equipment only through a prescription ensures that pregnant women will receive professional care that contributes to their health and to the health of their babies, and that ultrasound will be used when medically indicated.

Fetal Keepsake Videos: "Performing prenatal ultrasounds without medical oversight may put a mother and her unborn baby at risk," says Phillips. "The bottom line is: Why take a chance with your baby's health for the sake of a video?"

Fetal keepsake videos are viewed as a problem because there is no medical benefit derived from the exposure. Further, there is no control on how long a single imaging session will take or how many sessions will occur.

FDA is aware of entrepreneurs that are commercializing ultrasonic imaging of fetuses by making keepsake videos. In some cases, the ultrasound machine may be used for as long as an hour to get a video of the fetus.

Doppler Ultrasound Heartbeat Monitors: Similar concerns surround the OTC sale of Doppler ultrasound heartbeat monitors. These devices, which people use to listen to the heartbeat of a fetus, are currently marketed legally as "prescription devices" that should only be used by or under the supervision of a health care professional.

"When the product is purchased over the counter and used without prior consultation with a health care professional, there is no oversight of how the device is used and little or no medical benefit derived from the exposure," Phillips says. "The number of sessions or the length of a session to which a fetus is exposed is uncontrolled, thus raising the potential for harm to the fetus."

For More Information

Taking a Close Look at Ultrasound
www.fda.gov/consumer/updates/ultrasound032408.html

Fetal Keepsake Videos (FDA-CDRH)
www.fda.gov/cdrh/consumer/fetalvideos.html

FDA Cautions Against Ultrasound "Keepsake" Images
www.fda.gov/fdac/features/2004/104_images.html

tag: FDA Advisory, ultrasonic fetal scanning, fetal keepsake videos, fetal heartbeat monitors, CDRH, cavitation, unborn baby risk, Doppler Ultrasound Heartbeat Monitors

Diabetes And Other Related Diseases

I came across a post today by WillYouMind, How To Deal With Diabetes Related Diseases.
While not an extensive report on Diabetes, I think you can get some education there. I for one did not know that diabetes leads to neuropathy.
tag: Diabetes, neuropathy

China Places New Oversight over Heparin Production.

New York Times is reporting about Chinese State Food and Drug Administration taking action on heparin manufacture. Why Now? Why only Heparin? why not food, toys and anything else that is produced in China and exported.
SHANGHAI — China’s top drug safety agency has ordered its local bureaus to increase supervision over the production of heparin, a blood-thinning drug that has been linked to at least 19 deaths and hundreds of allergic reactions in the United States, China’s state-run news agency reported Friday.
Read more at NY Times.
tag: Heparin, Chinese Heparin, Chinese FDA

FDA Warning, Salmonella Risk with Cantaloupes

FDA Warns of Salmonella Risk with Cantaloupes from Agropecuaria Montelibano
The agency detains products from the Honduran manufacturer

The U.S. Food and Drug Administration has issued an import alert regarding entry of cantaloupe from Agropecuaria Montelibano, a Honduran grower and packer, because, based on current information, fruit from this company appears to be associated with a Salmonella Litchfield outbreak in the United States and Canada. The import alert advises FDA field offices that all cantaloupes shipped to the United States by this company are to be detained.

In addition, the FDA has contacted importers about this action and is advising U.S. grocers, food service operators, and produce processors to remove from their stock any cantaloupes from this company. The FDA also advises consumers who have recently bought cantaloupes to check with the place of purchase to determine if the fruit came from this specific grower and packer. If so, consumers should throw away the cantaloupes.

To date, the FDA has received reports of 50 illnesses in 16 states and nine illnesses in Canada linked to the consumption of cantaloupes. No deaths have been reported; however, 14 people have been hospitalized. The states are Arizona, California, Colorado, Georgia, Illinois, Missouri, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Tennessee, Utah, Washington, and Wisconsin.

Recallr: Salmonella Risk with Cantaloupes from Agropecuaria Montelibano, Honduras

tag: FDA Warning, Salmonella Risk, Salmonella Risk with Cantaloupes

Epilepsy Drug Carbamazepine May Increase Risk of Serious Skin Reactions In Patients of Asian Ancestry

OTTAWA - Health Canada is advising Canadians about new safety information for carbamazepine, a drug used to treat epilepsy, mania, bipolar disorder and a painful condition of the face called trigeminal neuralgia. In Canada, carbamazepine is sold under the brand name Tegretol, and multiple generic names.

Health Canada has revised the prescribing information for Tegretol, and is currently revising the prescribing information for all generic carbamazepine products to include information about an increased risk of serious skin reactions for patients of Asian ancestry, as compared to patients of non-Asian ancestry. Novartis Pharmaceuticals Canada, the manufacturer of Tegretol in Canada, has issued a letter to health care professionals to inform them of the new safety information.

Serious and sometimes fatal skin reactions known as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been known to occur very rarely with carbamazepine. While all patients treated with carbamazepine are at risk for these serious skin reactions, the risk is approximately 10 times higher in Asian countries than in Western countries. In addition, studies have suggested that patients of Asian ancestry may also be at increased risk if they take carbamazepine.

There is a genetic test that may be useful in identifying a particular genetic marker in patients of Asian ancestry. This marker has been linked to an increased risk of developing serious skin reactions to carbamazepine. Patients of Asian - particularly Han Chinese - ancestry may wish to discuss this test with their doctors as a possible screening tool to determine if they are at increased risk of serious skin reactions.

All patients taking carbamazepine - including those who have had the genetic test done, and regardless of their ethnicity - should immediately consult a physician if they develop any signs of serious skin reactions such as a rash, red skin, blistering of the lips, eyes or mouth, or peeling skin with an accompanying fever.

Patients who have been taking carbamazepine for more than a few months without developing skin reactions are at low risk of these events ever developing from carbamazepine.

Patients who have previously had serious skin reactions during treatment with carbamazepine, regardless of ethnicity, should not take carbamazepine again and should consult their health care professional as soon as possible so that a decision can be made regarding alternative treatments.

Patients taking carbamazepine should not stop treatment before speaking with their doctor.

The prescribing information for all generic carbamazepine-containing products is being revised to include the same new safety information for serious skin reactions that has been added to the Tegretol prescribing information. The following is a list of carbamazepine-containing products being sold in Canada. Each product may have multiple formulations, including tablets, suspension, chewtabs, or controlled release:

• Apo-carbamazepine (Apotex Incorporated)
• Bio-carbamazepine (Biomed 2002 Inc.)
• Carbamazepine (Pro Doc Limitée)
• Dom-carbamazepine (Dominion Pharmacal)
• Gen-carbamazepine (Genpharm ULC)
• Mazepine (Valeant Canada Limitée/Limited )
• Novo-carbamaz (Novopharm Limited)
• Nu-carbamazepine (Nu-Pharm Inc.)
• PHL-carbamazepine (Pharmel Inc.)
• PMS-carbamazepine (Pharmascience Inc.)
• Sandoz-carbamazepine (Sandoz Canada Incorporated)
• Taro-carbamazepine (Taro Pharmaceuticals Inc.)
• Tegretol (Novartis Pharmaceuticals Canada Inc.)

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

To report a suspected adverse reaction to these health products, please contact the Canada Vigilance Program of Health Canada by one of the following methods:

Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789

Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, Ontario, AL 0701C
K1A 0K9

E-mail: CanadaVigilance@hc-sc.gc.ca

The Canada Vigilance adverse reaction reporting form, including a version that can be completed and submitted online, is located in the MedEffect area of the Health Canada Web site.

tag: Health Canada, Drug Advisory, carbamazepine, epilepsy, mania, bipolar disorder, trigeminal neuralgia, Tegretol, Novartis Pharmaceuticals Canada, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis

Another firm, B. Braun Recalls Heparin Solutions (II)

Heparin is being recalled worldwide and now B. Braun Medical Inc is recalling the same. The Scientific Protein Laboratories LLC has supplied the raw heparin to B.Brown as well. The facts about Scientific Protein Laboratories LLC were released a long time ago.
Recallr: B. Braun Recalls Heparin Solutions (II)

tag: heparin recalls, B. Braun Medical Inc Recall, Scientific Protein Laboratories, oversulfated chondroitin sulfate, Changzhou SPL

Recallr: American Health Packaging Recalls Heparin Sodium Vial Products as Part of Broader Baxter Recall

American Health Packaging Announces a Recall of Approximately 1,400 Units of Heparin Sodium Vial Products as Part of Broader Baxter Recall
Units for Pharmacy Automated Equipment Part of Broader Recall
Recallr: American Health Packaging Recalls Heparin Sodium Vial Products as Part of Broader Baxter Recall
tag: Baxter Recall, FDA Recall, American Health Packaging Recall, Heparin Recall, AmerisourceBergen Corporation Recall

Keeping Up To Date With Glucose Meters And Test Strips.

Image from diabetes.com.au

Getting Up to Date on Glucose Meters

NOTE: FDA is reminding people with diabetes to use only the test strips that are recommended for use with their glucose meter. FDA is aware of instances where incorrect results were obtained when brands and models of meters and test strips were not used in proper combination. For more information, visit www.fda.gov/cdrh/oivd/test-strips.htm

On this page

• Tips for Proper Use

Using a glucose meter to monitor blood sugar is a daily part of life for millions of Americans. Glucose meters are usually small battery-operated devices, which make it convenient for people to check their glucose levels anywhere. Most work by "reading" a drop of blood the user has placed on a disposable test strip.

To begin testing, users place the test strip into a slot in the meter, prick a fingertip and then place a drop of blood onto the strip. Before pricking the skin, the user should clean the selected testing site to ensure it is free of sugar residues. If the site is not clean, the readings may not be accurate.

In a short time, the meter will show a result in its digital display window. Users record their test results and talk with their health care provider to help with overall disease management.

FDA reviews all glucose meters and test strips before they can be marketed to the public. The agency also requires that manufacturers demonstrate that their test system provides acceptable accuracy and consistency of results.

Recently, we have seen the emergence of advanced glucose meters that include features such as download capabilities that allow the transfer of test results to a home computer. Some meters can now test blood taken not from the fingertips, but from "alternate sites" such as the forearm and palm.

Tips for Proper Use

Read instructions carefully. Glucose meters and test strips must come with instructions for use. Your user manual should also include a toll-free phone number that you can use to contact the manufacturer. How often you use your glucose meter, and the results you should expect, should be based on the recommendations of your health care provider.

Use the test strips that are recommended for your glucose meter. It is important to only use the test strips that are specified for your glucose meter. Otherwise, the device may fail to give results or may generate inaccurate results.

Know that readings taken from "alternate sites" may not always be as accurate as readings from the fingertips. These readings can differ at times when glucose levels are changing rapidly. This is common after a meal, after taking insulin, during exercise, or when you are ill or under stress.

Use blood from a fingertip rather than an alternate site if you think your blood glucose is low, you don't normally have symptoms when your blood glucose is low, or the results from the alternate site doesn't match how you are feeling.

Know the factors that affect meter accuracy. These may include

• the amount of red blood cells (hemocrit) in the blood
• other substances present in the blood such as uric acid, glutathione, and vitamin C
• altitude, temperature, and humidity
• use of test strips developed as a less expensive option than the strips intended for a certain meter.

Perform quality-control checks with test control solutions to ensure that the test strips and meter are working properly together. Some meters may also provide electronic test strips that induce a signal to indicate if the meter (and only the meter) is working properly. In addition, perform quality control checks with control solutions regularly to ensure the meter is working properly.

Ask your health care provider to watch you test yourself. He or she can tell you if you are using the meter correctly.

Know when and how to clean your meter. Some meters need regular cleaning. Others don't need regular cleaning, but contain electronic alerts indicating when you should clean them. You should follow the directions given in the manual on how to clean the meter. Only the manufacturer can clean some meters.

Understand what the meter display means . The range of glucose values can be different among meters. Be sure you know how high and low glucose values are displayed on your meter. Sometimes they are displayed as “LO” or "HI" when the glucose level is beyond the range than the meter can measure.

Report problems to the manufacturer and to FDA. If you suspect that a death or serious injury was related to false glucose readings, follow the mandatory reporting procedure established by your hospital or user facility. Report adverse events not related to serious injuries to the device manufacturer. You can also report events to MedWatch, the FDA's voluntary reporting program at www.fda.gov/medwatch/report.htm.

For More Information

Reminder about Using Test Strips Recommended for Use with Glucose Meters
www.fda.gov/cdrh/oivd/test-strips.html

Glucose Meters and Diabetes Management
www.fda.gov/diabetes/glucose.html

tag: FDA Services, Glucose Meters, Glucose test strips, Diabetes Awareness, monitor blood sugar, hemocrit, uric acid, glutathione, MedWatch,

Food Recall: Acme Cinnamon Rolls with Icing Recalled

Check if you have the Cinnamon Rolls from ACME. Allergy alert.
Recallr: Acme Labeled Cinnamon Rolls with Icing Recalled
tag: FDA Recall, Acme Cinnamon Rolls with Icing Recall, ACME Recall, Food Recall, Allergy Alert

Toy Recall By QVC :Toy Puzzle Vehicle Sets

Another Toy recall due to lead paint standard violation and you should check your kid's toys.
Recallr: QVC Recalls Toy Puzzle Vehicle Sets

tag: Toy Recall, cpsc recall, QVC Recall, Toy Puzzle Vehicle Sets recall, Lead Paint Standard Violation

Pharmaceutical Outsourcing in China, A Guide.

As China has become one of the hottest areas for pharmaceutical and biopharmaceutical outsourcing, there is an urgent need for the Western pharma and biotech companies, in particular those small-sized ones who do not have sufficient internal resources to manage all steps of the outsourcing process, to have a complete collection of the information with regards to the current situation and service capabilities of the Chinese pharmaceutical outsourcing service providers. This guide is thus prepared to address these issues.

It provides answers to such questions as:

- Whether is it the right time to go to China for outsourcing?
- Who are those Chinese service providers?
- What can they do?
- How good is each of these individual Chinese CROs?
- Where are they located?
- How to approach them?
- How to ensure my outsourcing effort in China will be successful?

Companies Mentioned:

• AbMax Biotechnology Co. Ltd
• AcceleDev Chemical, Co. LLC
• AllyChem, Ltd
• Alputon, Inc
• AstaTech, Inc
• Asymchem Laboratories, Inc
• Beijing Honghui Meditech
• Beijing Joinn Pharmaceutical Center
• Beijing Pharma Sciences
• Beijing WisdomChem Co. Ltd
• BioDuro
• Bridge Pharmaceuticals
• Charles River Laboratories
• ChemExplorer
• ChemiK Co. Ltd
• Chemizon
• ChemPacific Corporation
• ChemPartner
• ChengYi Pharmaceuticals Co
• Chimica Laboratories
• China Gateway Pharma Products, Ltd
• Chiral Quest, Inc
• CrimsonPharma
• Crown Biosciences, Inc
• Daxian Chemical Institute, Ltd
• Ennova MedChem Group, Inc
• Excel Pharma Studies
• Fountain Medical Development, Ltd
• FuXin Hengton Fluorine Chemicals Co. Ltd
• HD Biosciences Co. Ltd
• Huaxipharm Co. Ltd
• Jiangsu Zhongdan Drug Research Co. Ltd
• Laviana Corporation
• Medicilon
• Nanjing Chemzam Pharmtech Co. Ltd
• ONICHEM
• Paramax International, Inc
• Pharmabridge, Inc
• Pharmaron
• Porton Corporation
• Radiant Pharma & Tech Co., Ltd
• ScinoPharm Kunshan
• Shanghai LeadChem Co. Ltd
• Shanghai SINCH Pharmaceuticals Tech. Co. Ltd
• Shanghai SynCores Technologies, Inc
• Sinova, Inc
• StarVax, Inc
• Sundia Meditech Co. Ltd
• SynChem, Inc
• Synergetica, Inc
• Synergy PharmaTech Co. Ltd
• Tyger Scientific, Inc
• United PharmaTech
• Vivo Development, Ltd
• WatsonChem
• Wilmington PharmaTech
• WuXi PharmaTech
• 2Y-CHEM, Ltd
• Yield Pharma
• Zannan Pharma
• Zhejiang Qiming Pharmaceuticals Co. Ltd
  

Guide to Pharmaceutical Outsourcing in China Sample
tag: Medical Business, pharmaceutical outsourcing, China

Eighteen states have filed an antitrust suit against Abbott Laboratories, Over Tricor

WILMINGTON, Del. - Eighteen states have sued Abbott Laboratories in federal court, alleging the drug maker blocked generic competition for a popular cholesterol medication, TriCor, state officials said Tuesday.
The antitrust lawsuit against Abbott and French drug company Fournier Industrie et Sante and Laboratories Fournier SA, charges the companies sought to block competition for a cheaper, generic version of the prescription drug TriCor.
The cholesterol drug accounted for more than $1 billion of Abbott's sales last year. The North Chicago, Ill.-based company had total revenue of $25.9 billion in 2007.

More news at Chicago Tribune
The Florida AG's website
tag: TRICOR, Fournier Industrie, Abbot Laboratories, Drug Companies, cholesterol medication,

Artiss, New Medical Adhesive to Treat Burn Patients, Approved By FDA

FDA Approves New Medical Adhesive to Treat Burn Patients

The U.S. Food and Drug Administration today approved a new medical adhesive (a fibrin sealant) called Artiss for use in attaching skin grafts onto burn patients.

Fibrin sealants are tissue adhesives that contain the proteins fibrinogen and thrombin, which are essential in the clotting of blood. Artiss (Fibrin Sealant, VH S/D 4) differs from other fibrin sealants in that it contains a lower concentration of thrombin. This lower concentration allows surgeons more time to position skin grafts over burns before the graft begins to adhere to the skin. Artiss also contains aprotinin, a synthetic protein that delays the break down of blood clots.

"The approval of Artiss can help surgeons using a fibrin sealant to fine tune graft placement on burn sites," said Jesse L. Goodman M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. "The approval also provides an additional choice for health care professionals in providing burn treatment."

The fibrinogen and thrombin proteins in Artiss are derived from human plasma, collected from FDA-licensed plasma centers. Both proteins undergo purification and virus inactivation treatments to reduce the risk of blood-transmissible infections.

During a multicenter clinical trial, investigators evaluated Artiss for its ability to attach skin grafts on two wound sites for 138 patients. At one test site, the skin graft was fixed with Artiss; at the other test site, the graft was fixed with surgical staples. The results showed that Artiss was, within a statistical error, as good as staples to attain complete wound closure.

Frequent adverse events, seen in both treatment groups, included bleeding and fluid collection in the tissues, both of which are common during skin grafting procedures. Artiss is manufactured by Baxter Healthcare Corporation, Deerfield, Ill.

tag: FDA Approval, Artiss, human plasma, Baxter Healthcare,

Food Recalls; Spelt Bread, Bass Pro Shops Uncle Buck's Light 'n Krispy Original and Light 'n Krispy Hot & Spicy Fish Batter Mixes

Food Recalls from FDA
Recallr has tow new records about food recalls, fish batter and spelt bread.

Recallr: Williams Foods, Inc. Recalls Bass Pro Shops Uncle Buck's Light 'n Krispy Original and Light 'n Krispy Hot & Spicy Fish Batter Mixes


Recallr: Food For Life Baking Company of Corona Recalls Spelt Bread (UPC# 07347200168)

tag: FDA Recall, food recall, Spelt Bread recall, Bass Pro Shops Uncle Buck's Light 'n Krispy Original mix recall, Light 'n Krispy Hot & Spicy Fish Batter Mix recall

Drug Safety Information: Spiriva HandiHaler (Tiotropium)

[03/18/2008] Boehringer Ingelheim and FDA notified healthcare professionals that ongoing safety monitoring has identified a possible increased risk of stroke in patients who take Spiriva. This product contains tiotropium bromide and is used to treat bronchospasm associated with chronic obstructive pulmonary disease. Boehringer Ingelheim reported to the FDA that it has conducted an analysis of the safety data from 29 placebo controlled clinical studies (“pooled analysis”). Based on data from these studies, the preliminary estimate Drug Advisory, s of the risk of stroke are 8 patients per 1000 patients treated for one year with Spiriva, and 6 patients per 1000 patients treated for one year with placebo. This means that the estimated excess risk of any type of stroke due to Spiriva is 2 patients for each 1000 patients using Spiriva over a one year period.

It is important to interpret these preliminary results with caution. FDA is working with Boehringer Ingelheim to further evaluate the potential association between Spiriva and stroke. FDA has not confirmed these analyses and while pooled analyses can provide early information about potential safety issues, these analyses have inherent limitations and uncertainty that require further investigation using other data sources. Patients should not stop taking Spiriva HandiHaler before talking to their doctor, if they have questions about this new information. This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.

[March 18, 2008 - Early Communication about an Ongoing Safety Review - FDA]
tag: FDA, Drug Advisory, Boehringer Ingelheim, Spiriva, tiotropium bromide, bronchospasm, chronic obstructive pulmonary disease,

Yale Get Funded to Study Exercise for Women with Cancer

New Haven, Conn. — A Yale-developed exercise program designed to reduce bone loss and prevent weight gain in women with cancer is being funded with a $2.2 million grant from the National Cancer Institute.

The principal investigator, M. Tish Knobf, the American Cancer Society Professor at Yale University School of Nursing and a member of Yale Cancer Center, said there are more than 10 million cancer survivors in the United States, and 22 percent are women diagnosed with breast cancer.

“Cancer survivors face persistent physical symptoms as well as psychological distress when treatment ends,” Knobf said. “For long-term survivors, there are additional concerns related to late effects of cancer therapy, such as bone loss.”

She and her team conducted a pilot study to look at the effects of exercise and found that 88 percent of the women adhered to the program, maintained their weight, had no changes in bone mass, and improved psychologically.

“Weight gain, changes in body composition, decreased physical functioning, bone loss, and menopause in women treated for cancer may increase risks for cardiovascular disease, diabegtes, and osteoporosis,” Knobf said. “With an estimated 64 percent of cancer survivors now living longer than five years, interventions are needed to reduce the risk of cancer recurrence, secondary cancers, and health risks for other chronic illnesses.”

Co-investigators Lyndsay Harris, M.D., and Karl Insogna, M.D., will provide additional expertise to help monitor the women enrolled in the study. Harris, associate professor of medical oncology and director of the Yale Cancer Center Breast Cancer Program, studies the molecular classifications of breast cancer, particularly in minority women. Insogna, director of the Yale Bone Center and professor internal medicine, has clinical expertise on the disease-related causes of bone loss.

PRESS CONTACT
Jacqueline Weaver
203-432-8555

tag: Medical Research, bone loss, American Cancer Society, Yale Cancer Center, Weight gain, cardiovascular disease, diabegtes, osteoporosis, Breast Cancer Program,

Altered Heparin Source Is Being Traced.

Scientists investigating a mystery contaminant in the blood thinner heparin are closing in on what they believe is a counterfeit substance, most likely made in China from animal cartilage, that was chemically altered to act like the real drug.

The United States Food and Drug Administration declined to confirm that statement and a spokeswoman said the agency would have no comment.

But in interviews, heparin experts in China and the United States — including one researcher involved in the inquiry — said that a chemically altered substance called over-sulfated chondroitin sulfate is probably the contaminant that the F.D.A. says is linked to hundreds of allergic reactions and 19 deaths.

Even so, researchers said they were not certain that the contaminant, constituting between 5 percent and 20 percent of the drug, is what is causing the allergic reactions, nor do they know precisely how or when it was mixed into the active ingredient.

Continue read at NY Times.

tag: Heparin Recall, over-sulfated chondroitin sulfate, chondroitin sulfate,

FDA.GOV New Home Page Design

If you have visited FDA website today you would have noticed the change they have made to the site. I have not tested all aspects of the site (well I am trying to get used to the site!) but I like the feel of it. Due to the reporting I do I visit the site daily and at least visit three layers deep. So soon I will be able to tell more.
I feel good that I answered one of those pop up surveys a few weeks ago. Thank you FDA.

Sleep Apnea Home Testing Approved by Medicare

The Centers for Medicare & Medicaid Services (CMS) today expanded Medicare coverage for continuous positive airway pressure (CPAP) devices to include beneficiaries who have been diagnosed, using a home sleep test, with obstructive sleep apnea. CMS also announced changes to simplify certain test requirements.

Obstructive Sleep Apnea (OSA) is a condition in which periods of temporary suspension in breathing (apnea) occur during sleep. In most instances, OSA is diagnosed by counting the number of sleep disturbances that occur during a specific time interval. Up to four million Medicare beneficiaries may suffer from some form of OSA.

The CPAP devices provide air pressure through a face mask to help keep breathing passages open during sleep. Medicare’s current policy provides CPAP coverage only for beneficiaries who have OSA diagnosed using a specific type of sleep test called polysomnography in an attended sleep laboratory setting. CMS’ new policy will add coverage for CPAP following a positive at-home sleep test.

In the home tests, the patient wears a device during sleep that collects and records data about airflow and other measurements. The patient takes the device to the physician, who uses the data collected by the device to determine whether the patient has obstructive sleep apnea or needs further sleep studies or assessment.

Some patients with OSA do not continue with CPAP treatment or do not improve on treatment. Thus, CMS is limiting initial coverage of CPAP for OSA to twelve weeks to determine if the beneficiary will respond to the CPAP treatment. Long term CPAP is covered for those beneficiaries who continue and respond to treatment.

“Our revised policy provides more options for Medicare beneficiaries and their treating physicians,” said CMS Acting Administrator Kerry Weems. “At the same time, we remain vigilant to ensure that Medicare payments for these services do not create incentives for inappropriate use.”

CMS will continue to monitor the use of the CPAP home testing services, examining the potential for fraud and abuse as well as making recommendations to implement appropriate safeguards to mitigate potential risk.

The final national coverage determination announced today is available on the CMS web site at www.cms.hhs.gov/center/coverage.asp.

tag: medicare, , obstructive sleep apnea, home sleep test, continuous positive airway pressure, Centers for Medicare & Medicaid Services

Poultry Recall: Cagle's Inc

Check you Freezers and Fridges.
Recallr: Poultry Recall: Cagle's Inc Recalls fresh and frozen poultry giblets and fresh carcasses with giblets inserted
tag: Food Recall, FSIS Recall, USDA Recall, Chicken Recall, poultry Recall

Despite Recalls Drug Companies Stand By China.

As we informed today that FDA itself is seeking to establish FDA offices in China, Boston Globe has an article that despite worldwide recalls of Chinese made drugs, more and more drug companies are flocking to China to reduce production costs, and of course larger profits.
Of course when questioned the companies say problems such as the recent heparin related deaths in the USA and the subsequent all heparin recall in USA and Germany, Panama's antifreeze lazed medicine and the tainted leukemia drugs found in China itself are isolated incidents. They say they have the same quality-control standards in China. But I wonder if they are following these standards.
The article mentions the FDA itself thinks that there are many companies that follow the rules while there many who are in the other end of the spectrum. ""While some Chinese [drug] companies are state-of-the art in technology and manufacturing expertise, many are at the opposite end of the spectrum," FDA deputy commissioner Murray Lumpkin told Congress last year."
What ever the reasons, it is hard to believe the damage these drug companies are causing to general populace. So I invite you to read this article by Boston Globe, which tries to look at the issue from many fronts, including Massachusetts's own companies that manufacture drugs in China.
tag: Drug Companies, Drug Manufacture, FDA in China, heparin recall, Chinese made drugs,

FDA on path to establish offices in China

FOR IMMEDIATE RELEASE March 14, 2008

Media Inquiries: Stephanie Kwisnek, 301-827-0955 Consumer Inquiries: 888-INFO-FDA

FDA Takes Next Step in Establishing Overseas Presence
Agency on path to establish offices in China

In an important development, the U.S. Food and Drug Administration has received approval from the U.S. State Department to establish eight full time permanent FDA positions at U.S. diplomatic posts in the People's Republic of China, pending authorization from the Chinese government.

This is an important step forward in the FDA's plans to hire and place FDA staff in China over the next 18 months. In addition, the FDA will be hiring a total of five local Chinese nationals to work with the new FDA staff at the U.S. Embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou.

"In an age when a border is not a barrier, the globalized economy demands nothing less than heightened regulatory interoperability, information exchange, and cooperation, especially on product quality and enforcement matters," said Murray M. Lumpkin, M.D., deputy commissioner for International and Special Programs, FDA. "Along with the important Memoranda of Agreement signed with two FDA counterpart Chinese agencies, our efforts to fill permanent FDA positions in China are a significant step toward ensuring access to safe food, drugs, and medical devices in the global market."

Building the FDA's capacity outside of the United States supports the agency's "Beyond our Borders" initiative. The initiative facilitates the building of stronger cooperative relationships with the FDA's counterpart agencies around the world and enhanced technical cooperation with foreign regulators. The permanent overseas offices in China will also allow greater access for inspections and greater interactions with manufacturers to help assure that products that are shipped to the United States meet U.S. standards for safety and manufacturing quality.

For additional information on the FDA's international programs, please visit: http://www.fda.gov/oia/overview.html. For more information on the historic Memoranda of Agreement signed in December 2007, between the United States and The People's Republic of China, please visit: http://www.hhs.gov/news/press/2007pres/12/pr20071211a.html.

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tag: FDA, People's Republic of China, globalized economy, Beyond our Borders,

What Is Health Level Seven, HL7

Self Proclaimed to be "Level Seven" of Healthcare service, HL7 provides valuable service to our community. "Level Seven" refers to the highest level of the ISO (International Organization for Standardization) communications model for OSI's (Open Systems Interconnection) Application Level. The application level addresses definition of the data to be exchanged, the timing of the interchange, and the communication of certain errors to the application. The seventh level supports such functions as security checks, participant identification, availability checks, exchange mechanism negotiations and, most importantly, data exchange structuring.

Health Level Seven is one of several American National Standards Institute (ANSI) -accredited Standards Developing Organizations (SDOs) operating in the healthcare arena. Most SDOs produce standards (sometimes called specifications or protocols) for a particular healthcare domain such as pharmacy, medical devices, imaging or insurance (claims processing) transactions. Health Level Seven’s domain is clinical and administrative data.

Headquartered in Ann Arbor, MI, Health Level Seven is like most of the other SDOs in that it is a not-for-profit volunteer organization. Its members-- providers, vendors, payers, consultants, government groups and others who have an interest in the development and advancement of clinical and administrative standards for healthcare—develop the standards. Like all ANSI-accredited SDOs, Health Level Seven adheres to a strict and well-defined set of operating procedures that ensures consensus, openness and balance of interest. A frequent misconception about Health Level Seven (and presumably about the other SDOs) is that it develops software. In reality, Health Level Seven develops specifications, the most widely used being a messaging standard that enables disparate healthcare applications to exchange keys sets of clinical and administrative data.

Members of Health Level Seven are known collectively as the Working Group, which is organized into technical committees and special interest groups. The technical committees are directly responsible for the content of the Standards. Special interest groups serve as a test bed for exploring new areas that may need coverage in HL7’s published standards. A list of the technical committees and special interest groups as well as their missions, scopes and current leadership is available on this web site.

HL7's Vision

To create the best and most widely used standards in healthcare.

HL7's Mission

HL7 provides standards for interoperability that improve care delivery, optimize workflow, reduce ambiguity and enhance knowledge transfer among all of our stakeholders, including healthcare providers, government agencies, the vendor community, fellow SDOs and patients. In all of our processes we exhibit timeliness, scientific rigor and technical expertise without compromising transparency, accountability, practicality, or our willingness to put the needs of our stakeholders first.

tag: HL7, healthcare, ISO, OSI, SDO, Level Seven,

Toys and Car Seat recalls

Recallr, the recall resource, has the following items listed. Parents you may want to follow and let every one near you know!

Toy Airplanes, Cars, and Motorcycles Recalled by S.U. Wholesale

Target Recalls Toy Sundae Sets Made By Battat Inc.

Battat Recalls Additional Magnetic Construction Sets

GRACO Recalls Cargo Booster Seats (CHILD RESTRAINT SYSTEMS)


tag: NHTSA Recall, CHILD SEAT recall, GRACO RECALL, GRACO CHILD SEAT recall,Battat Recall, Magnetic Construction Sets Recall, CPSC recall,cpsc recall, Toy Recall, Target Recall, Toy Sundae Sets Recall,Toy Airplanes recall, Toy Cars Recall, Toy Motorcycles Recall, Lead Paint Violation, X Force Commander Toy Airplanes recall, Super Famous Toy Cars Recall,

Wining And Dinning Doctors To Sell Medicine Or To Keep You Drugged.

Catch 22 for you. By reading this, you might get sick to your stomach which might make you want to visit your Doctor, only to get some drug prescribed only because a drug company paid for the hostess in the night club he visited last night!

I just realized that my doctor resents (in good sense) my visits because she has to give me, all the information on medicines that she asks me to to take. I will research about these before I take them. Well I will let you read about the Congressional committees investigation into Drug companies' sales tactics held this morning. But then again there are GOOD doctors;
One doctor who says he has resisted the pitches of sales reps is Dr. Jerome P. Kassirer, a professor at Tufts University School of Medicine. "I don't see drug reps and haven't seen them for probably 35 years,"

You will really understand the value of the above doctor when compared to the statement below!
"Quote from a senior marketing executive at Parke-Davis: "I want you out there every day selling Neurotonin. Neurotonin is more profitable than Accupril, so we need to focus on Neurotonin. Pain management, now that's money…. I don't want to see a single patient coming off Neurotonin before they've been up to at least 4,800 milligrams a day. I don't want to hear that safety crap, either."
A spokesman for Parke-Davis did not immediately respond to ABC News' request for comment."

To sell their drugs, pharmaceutical companies hire former cheerleaders and ex-models to wine and dine doctors, exaggerate the drug's benefits and underplay their side-effects, a former sales rep told a Congressional committee this morning.
Shahram Ahari, who spent two years selling Prozac and Zypraxa for Eli Lily, told a Senate Aging Committee chaired by Sen. Herb Kohl, D-Wisc., that his job involved "rewarding physicians with gifts and attention for their allegiance to your product and company despite what may be ethically appropriate."

Ahari claims that drug companies like hiring former cheerleaders and ex-models, as well as former athletes and members of the military, many of whom have no background in science.

"On my first day of sales class, among 21 trainees and two instructors, I was the only one with any level of college-level science education," Ahari told ABCNews.com on Tuesday.

During their five-week training class, Ahari claims that instructors teach sales tactics, including how to exceed spending limits for important clients, being generous with free samples to leverage sales, using friendships and personal gifts to foster a "quid pro quo" relationship, and how to exploit sexual tension.

"The nature of this business is gift-giving," says Ahari. He claims that he's heard stories about sales reps helping to pay the cost of a doctor's swimming pool and another doctor who was routinely taken to a nightclub where a hostess was paid to keep him company.

tag: Drug Trials, Drug Sales, pharmaceutical companies, Eli Lily, Parke-Davis,

Leftbefores! Weight Control With A Little Help From Portion Control

When ever we visit restaurants, they almost always serve more food than one person needs but can eat, at one meal.
So we go ahead and gulp the food down since we already know we are going to pay for it. Then we complain about how full we are!. So what should we do?
For starters we split an entrée between two if WE happen to be at a lunch or dinner table in a restaurant. So it is all good and everyone is eating correctly. What if I am alone at the restaurant? Well it is easy to ask for a "to-go" box. But this time do it before the end of the meal! as soon as your lunch or dinner brought to the table, wrap up half your meal in the to-go box or bag. Take the leftbefores home, refrigerate and enjoy another meal or a snack tomorrow.

This is the first entry in a new series, baby steps in weight control, that you can use to fight the weight problems in small steps. Come back for more simple weight control steps.

tag: Portion Control, Weight Control, leftovers, leftbefores, baby steps in weight control,

Recallr: Westland/Hallmark Meat Company president defends himself in congressional testimony

Westland/Hallmark Meat Company President Steve Mendell testifies under subpoena today.
Recallr: Westland/Hallmark Meat Company president defends himself in congressional testimony

tag: USDA recall, food recall, Beef Recall, Hallmark/Westland Meat Packing, Hallmark/Westland Meat Packing recall, animal-abuse, FSIS, adulterated beef, Non-Ambulatory Disabled Cattle

Calculate the size of your Digital footprint!

Check out about you digital footprind, digital shadow and your eWaste generation.
WeSeePeople: How big is your Digital footprint? Discuss with your Digital Shadow!
tag: Digital Footprint, digital universe, Digital Shadow, VoIP, eWaste, Personal Digital Footprint Calculator

Weight Loss, Maintain It With Group Sessions and Counseling.

COLORADO SPRINGS, Colo., March 11 — People who shed weight and want to keep it off might benefit from monthly personal contact interventions, researchers reported at the American Heart Association’s Conference on Nutrition, Physical Activity and Metabolism.

Results of the study will also be simultaneously published in the Journal of the American Medical Association.

In a test of three ways that might help people maintain weight loss, those who received monthly personal counseling were best at keeping off unwanted pounds. Overall, 42 percent of the study members maintained at least a 4-kilogram (9-pound) weight loss for 30 months.

“We know how to help people lose weight in a healthy way, but we know very little about how to help them to keep the weight off,” said Laura P. Svetkey, M.D, lead author of the study and professor of medicine at Duke University Medical Center in Durham, N.C. “This study is the longest and largest to test strategies for long-term weight loss maintenance, and it suggests that long-term weight control is an achievable goal.

“The United States is in the midst of an obesity epidemic, one that portends serious future health consequences. Overweight and obesity are the leading cause of high blood pressure, diabetes and abnormal cholesterol, which are leading causes of cardiovascular disease, which is, in turn, the leading cause of death in this country,” Svetkey said. “So if we really want to get to the root causes of these disorders, we need to address the obesity epidemic.”

Despite the importance of obesity control, few studies have tested strategies to maintain weight loss over long periods.

Svetkey and her colleagues enrolled 1,685 participants in the two-phase Weight Loss Maintenance trial, which was conducted at four clinical centers in the United States.

Phase I consisted of 20 weekly group sessions of 18-25 participants held over six months, during which trained counselors emphasized three key elements to weight loss — consuming fewer calories, increasing moderate physical activity, and eating a healthy diet. Researchers recommended DASH (Dietary Approaches to Stop Hypertension), a diet rich in fruits, vegetables, whole-grain and high fiber foods, that uses low-fat and fat-free dairy products and is low in total and saturated fat and sodium. DASH lowers blood pressure and cholesterol even without weight loss.

Counselors helped participants use tools like self-monitoring and goal-setting, and helped them remember why they wanted to lose weight in the first place. The group sessions also provided study members with social support from other participants.

At the end of Phase I, 61 percent of the participants in the trial were eligible for Phase II, which lasted for 30 months, because they had lost at least nine pounds and as much as 66 pounds.

Thirty-eight percent of people in Phase II were African-American and 37 percent were male. “This is important because men are often underrepresented in weight loss studies, and obesity disproportionately affects African Americans,” Svetkey said.

Researchers randomly assigned the volunteers to one of three groups:

• Personal contact (PC) — Participants talked with an interventionist (monthly, nine times by telephone and three times face-to-face each year) who provided personal counseling and encouragement.
• Interactive technology (IT) — Study members had access to an interactive Web site on which they could record and track their exercise and calorie intake; set goals and monitor their progress toward them; and communicate with others in the IT group.
• Self-directed (SD) — Participants were urged to maintain their weight loss and then sent off without further intervention.
Results from the trial after 30 months included:
• Overall, 71 percent weighed less than when they began Phase I. The difference in the percentage of each group that weighed less was statistically significant — PC group (77 percent); IT group (69 percent) and SD group (67 percent).
• Thirty-seven percent of enrollees weighed at least 5 percent below their beginning weight. Again, the PC participants (42 percent) significantly out-performed those in the SD (34 percent) and IT (29 percent) groups.
• Among all study members, 32 percent weighed no more than 3 percent above their weight at randomization. However, differences between the three groups — SD (29 percent), IT (29 percent) and PC (36 percent) — were not significantly different statistically.
• Although at 24 months the average weight regained by the IT group was less than that of the SD arm, researchers found no difference between the two at 30 months.

“The effects we observed were modest,” Svetkey said. “The personal contact group regained about 3.3 pounds less than the self-directed group.”

Even a small weight loss can have potential health benefits, she noted.

“Each pound of weight loss can lower blood pressure by as much as a millimeter of mercury, and the more weight you lose, the bigger the blood pressure effect,” Svetkey said. “Each pound of weight loss is estimated to lower the risk of developing diabetes by 8 percent, which is quite impressive.

“Clearly more research is needed to refine these maintenance interventions to make them more effective, but this study is an important step in the right direction.”

The study was conducted at four clinical sites: Duke, Pennington Biomedical Research Center, Johns Hopkins University and the Kaiser Permanente Center for Health (CHR) Research, which also served as the coordinating center.

Co-authors are: Victor J. Stevens, Ph.D. (CHR Coordinating Center); Phillip J. Brantley, Ph.D. (Pennington); Lawrence J. Appel, M.D. (Hopkins); Jack F. Hollis, Ph.D. (CHR); Catherine M. Loria, Ph.D. (NHLBI); and William M. Vollmer, Ph.D.; Cristina M. Gullion, Ph.D.; and Kristine Funk, M.S. (all at the CHR coordinating center.)

The National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH) funded the study.

Statements and conclusions of abstract authors that are presented at American Heart Association/American Stroke Association scientific meetings are solely those of the abstract authors and do not necessarily reflect association policy or position. The associations make no representation or warranty as to their accuracy or reliability.

tag: Weight-loss, Weight loss, Nutrition, Physical Activity, Metabolism, obesity control, Dietary Approaches to Stop Hypertension, NHLBI, National Institutes of Health

Better Controll Of Insulin-resistant Type 2 Diabetes With Weight-loss and Lifestyle Change.

DALLAS — March 11, 2008 — Weight-loss and major lifestyle changes may be more effective than intensive insulin therapy for overweight patients with poorly controlled, insulin-resistant type 2 diabetes, according to a diabetes researcher at UT Southwestern Medical Center.

The National Heart, Lung, and Blood Institute of the National Institutes of Health recently halted part of an ongoing clinical trial on diabetes and heart disease after more than 250 people died while receiving intense treatment to drive their blood glucose levels below current clinical guidelines.

The evidence is compelling that when insulin levels are high, certain tissues are overloaded with fatty molecules, which leads to insulin resistance. And yet, the high blood glucose levels of many obese patients with insulin-resistant type 2 diabetes are being treated with increasing amounts of insulin in an attempt to overpower that resistance. While high doses of insulin may lower glucose levels, it will also increase the fatty molecules and may cause organ damage.
In a commentary in the March 12 issue of The Journal of the American Medical Association, Dr. Roger Unger, professor of internal medicine, wrote about the recent findings of his own and other labs that link insulin resistance to excess accumulation of fatty molecules in liver and muscle.

Dr. Unger, who has investigated diabetes, obesity and insulin resistance for more than 50 years said intensive insulin therapy is contraindicated for obese patients with insulin-resistant type 2 diabetes because it increases the fatty acids that cause diabetes. Instead, the most rational therapy eliminates excess calories, thereby reducing the amount of insulin in the blood and the synthesis of the fatty acids stimulated by the high insulin. Giving more insulin simply increases body fat.

“Evolution was unprepared for the change in the American diet to processed fast food and drive-through lanes,” he said. “There’s no way that our genes could evolve to gird themselves against the superabundance of very, very high-calorie foods that have flooded the U.S.”

Before the discovery of insulin, starvation was the only treatment for diabetes, said Dr. Unger, who is a member of the National Academy of Sciences.

“Today there are many treatment options, including bariatric surgery, if necessary, to lower the fat content in the body before you start giving insulin,” he said. “The fat is causing insulin resistance and killing the insulin-producing beta cells in the pancreas — that is what is causing type 2 diabetes.”

Giving more insulin simply channels the glucose into fat production. There is now a spectrum of therapies that improve diabetes by correcting the insulin resistance by reducing the body fat. Insulin treatment would be indicated only if all these fail.

Dr. Unger said insulin should be given to patients with insulin deficiency, but not if the insulin levels are already very high but ineffective. “Giving more insulin to an insulin-resistant patient is akin to raising the blood pressure of a patient with high blood pressure to overcome resistance to blood flow. Instead, you would try to reduce the resistance,” he said.

In the commentary, Dr. Unger said the increase in the number of patients with insulin-resistant type 2 diabetes can be traced to the epidemic of obesity that began in the U.S. after World War II, when food preparation was moved from the family kitchen to factories and companies that produce high-fat, calorie-dense foods, leading both men and women to consume substantially more calories on a daily basis. In addition, technological advancements such as televisions, computers and automobiles reduced the number of calories burned per day.

Type 2 diabetes occurs when the body is unable to make enough of the hormone insulin to compensate for insulin resistance. The condition affects between 18 million and 20 million people in the U.S.

Factors that increase the risk of type 2 diabetes include obesity, age and lack of exercise. Over a period of years, high blood sugar damages nerves and blood vessels, leading to complications such as heart disease, stroke, blindness and kidney disease.

Dr. Unger’s research is supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases, the Department of Veterans Affairs, and the Juvenile Diabetes Research Foundation.

Visit http://www.utsouthwestern.edu/endocrinology to learn more about UT Southwestern’s clinical services in endocrinology.
tag: diabetes, Weight-loss, type 2 diabetes, insulin, bariatric surgery,

Glaucoma Associated With Increased Risk of Cardiovascular Death In Black Patients, Stony Brook University Study

STONY BROOK, N.Y., March 11, 2008 – In a population of African origin, persons with diagnosed and treated glaucoma appeared to have an increased risk of death from cardiovascular causes, according to a study by Suh-Yuh Wu, and colleagues in the Departments of Preventive Medicine and Ophthalmology at Stony Brook University, the University of the West Indies, and the Cleveland Clinic Foundation. The study results are published in the March issue of Archives of Ophthalmology.

Glaucoma is one of the leading causes of visual impairment worldwide. The most common type, primary open-angle glaucoma, is especially prevalent in populations of African origin, including African-Americans, in which it is the foremost cause of blindness. According to Wu and coauthors, populations of African origin have higher rates of death from chronic disease than white populations and also tend to have and higher eye pressure (ocular hypertension).

Wu and colleagues studied 4,092 participants age 40 to 84 (average age 58.6) in the Barbados Eye Studies, which assessed a predominantly black population with similar ancestry to African-Americans. Initial visits occurred between 1987 and 1992. Height, weight and blood pressure were recorded. Interviews were conducted, and eye photographs and various eye measurements were taken, including eye pressure. Participants with specific findings were also referred for a comprehensive ophthalmologic examination.

At the beginning of the study, 300 participants had glaucoma, including 141 who had been diagnosed and treated. After nine years of follow-up, 764 (19 percent) of the participants had died. After adjusting for other factors, the researchers found that glaucoma was not associated with the risk of death overall. However, the risk of death from cardiovascular diseases was 38 percent higher in individuals with a previous diagnosis or treatment for open-angle glaucoma and 91 percent higher in those treated with one particular beta-blocker agent. Cardiovasular deaths were also 28 percent higher in those with ocular hypertension at the beginning of the study.

The researchers write in “Open-angle Glaucoma and Mortality” that “one explanation for the excess mortality found in persons with previously diagnosed open-angle glaucoma could be their longer duration of disease compared with those with newly diagnosed disease.” They also point out that another explanation could be related to the open-angle glaucoma treatment that patients received, as beta blockers and other medications used to treat open-angle glaucoma may harm the cardiovascular system and increase death risk.

The authors conclude that their research findings underscore the importance of careful monitoring and controlling of adequate intraocular pressure levels in the study population, and other high-risk populations. Close monitoring of treatment to lower the intraocular pressure and correction of its complications, they suggest, may prevent early deaths.

Wu’s coauthors include: Stony Brook University researchers Barbara Nemesure, Ph.D.; Anselm Hennis, Ph.D., FRCP; Leslie Hyman, Ph.D.; M. Cristina Leske, M.D., M.P.H.; and Andrew P. Schachat, M.D., of the Cleveland Clinic Foundation in Cleveland, Ohio.
SBU
tag: Medical Research, glaucoma,

Thailand By Passes Patents on Cancer Drugs to cut the cost of medicines for the Thai people.

Thailand's new health minister announced that he would urge the Thai government to continue to ignore patents on several cancer drugs, disappointing big pharmaceutical companies that had hoped Bangkok might roll back a policy of overriding patents in the name of public health.

The drugs' makers include Roche Holding AG and Novartis AG of Switzerland and Sanofi-Aventis of France.

Suphan Srithamma, a spokesman for the Thai health ministry, said that Minister Chaiya Sasomsup has decided to support the previous government's decision to ignore cancer-drug patents in a bid to cut the cost of medicines for the Thai people. The health ministry will make its recommendation to the Thai cabinet today, according to Dr. Suphan.

Thailand's previous health minister, Mongkol na Songkhla, decided in early January to issue compulsory licenses (a policy that permits lower-cost generics) for four drugs: Novartis's imatinib, also known as Gleevec; Novartis's breast-cancer drug letrozole, whose brand name is Femara; Sanofi-Aventis's docetaxel, marketed as Taxotere and used to fight lung and breast cancer; and Roche's erlotinib, whose trade name is Tarceva.

Continue to read at Wall Street Journal

tag: Drug Patents, Thailand, Roche Holding AG, Novartis AG, Sanofi-Aventis, cancer drugs, Thai health ministry, imatinib, Gleevec, letrozole, Femara, docetaxel, Taxotere, erlotinib, Tarceva, breast cancer

FDA Alert on Tussionex, a Long-Acting Prescription Cough Medicine

FOR IMMEDIATE RELEASE March 11, 2008

Media Inquiries: Christopher Kelly, 301-827-6242 Susan Cruzan, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Issues Alert on Tussionex, a Long-Acting Prescription Cough Medicine
Containing Hydrocodone
Agency gives new safety information on proper use of Tussionex as a cough suppressant

The U.S. Food and Drug Administration issued an alert today on the safe and correct use of Tussionex Pennkinetic Extended-Release Suspension in response to numerous reports of adverse events--including death--associated with the misuse and inappropriate use of this potent cough medication.

Tussionex is a prescription cough medicine containing hydrocodone, a narcotic ingredient, and the antihistamine chlorpheniramine. The product is approved for use in adults and children over the age of six years old, and should be given no more frequently than every 12 hours (“extended-release”).

“There is a real and serious risk for overdosing if this medication is not used according to the labeling,” said Curtis Rosebraugh, M.D., M.P.H., acting director of the FDA's Office of Drug Evaluation II. “Today’s action is an example of the FDA working with drug manufacturers throughout a product’s lifecycle to keep health care professionals and patients informed of new safety data.”

Adverse event reports associated with Tussionex have included life-threatening side effects and deaths in patients, including children. These reports reveal physicians and other health professionals are sometimes prescribing, and patients are sometimes taking, more than the recommended dose or taking the medication more frequently than every 12 hours. The reports also show that Tussionex is sometimes prescribed or given to children less than 6 years old, for whom this medication is not approved.

Highlights of the FDA’s recommendations to health care professionals include:

• Tussionex should not be used (is contraindicated) in patients less than 6 years old. FDA has received reports of death in children less than 6 years of age who have been prescribed Tussionex.
  
  
• Consult the prescribing information to determine the correct dose and dosing frequency of Tussionex. Tussionex is an extended-release formulation that should not be prescribed at an interval less than 12 hours.
  
  
• Discuss with the patient the amount of and frequency of Tussionex to be given. Instruct patients not to take, and parents not to administer Tussionex more frequently than every 12 hours.

Highlights of the FDA’s recommendations to patients include:

• One of the two ingredients in this long-acting cough product is hydrocodone, a narcotic. Too much hydrocodone can cause life-threatening breathing problems and death. Call your doctor right away if you have taken this medicine and have trouble breathing, slow heartbeat, severe sleepiness or cold, clammy skin.
  
  
• For Tussionex, use a medicine syringe or other device designed to measure liquid medications. A household teaspoon or tablespoon should not be used because the spoons vary in size and you may receive too much or too little of the medicine. Ask your doctor or pharmacist if you are unsure how to measure the medicine.
  
  
• If the cough is not controlled despite taking the prescribed dose at the recommended interval, talk to your doctor.

The manufacturer of Tussionex Pennkinetic Extended-Release Suspension (UCB Inc, Smyrna, Ga.) has agreed to update the labeling, including information that Tussionex should not be prescribed to or used in children less than 6 years of age, as well as the need for accurate dosing.

For more information and the full list of the FDA's recommendations, visit http://www.fda.gov/cder/drug/infopage/hydrocodone/default.htm

This alert does not impact short-acting cough products containing hydrocodone that can be given every 4 to 6 hours. However, the FDA is reviewing safety information on these other hydrocodone containing cough products and will provide updates as new information becomes available.

tag: FDA Alert, Tussionex, Hydrocodone, cough suppressant Alert, Tussionex Pennkinetic Extended Alert, cough medication Alert, antihistamine chlorpheniramine, narcotic ingredient, UCB Inc,

Teen Girls, One In Four Has STD, (Sexually Transmitted Diseases)

Chicago (March 11, 2008) – A CDC study released today estimates that one in four (26 percent) young women between the ages of 14 and 19 in the United States – or 3.2 million teenage girls – is infected with at least one of the most common sexually transmitted diseases (human papillomavirus (HPV), chlamydia, herpes simplex virus, and trichomoniasis). The study, presented today at the 2008 National STD Prevention Conference, is the first to examine the combined national prevalence of common STDs among adolescent women in the United States, and provides the clearest picture to date of the overall STD burden in adolescent women.

Led by CDC’s Sara Forhan, M.D., M.P.H., the study also finds that African-American teenage girls were most severely affected. Nearly half of the young African-American women (48 percent) were infected with an STD, compared to 20 percent of young white women.

The two most common STDs overall were human papillomavirus, or HPV (18 percent), and chlamydia (4 percent). Data were based on an analysis of the 2003-2004 National Health and Nutrition Examination Survey.

“Today’s data demonstrate the significant health risk STDs pose to millions of young women in this country every year,” said Kevin Fenton, M.D., director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention. “Given that the health effects of STDs for women – from infertility to cervical cancer – are particularly severe, STD screening, vaccination and other prevention strategies for sexually active women are among our highest public health priorities.”

“High STD infection rates among young women, particularly young African-American women, are clear signs that we must continue developing ways to reach those most at risk,” said John M. Douglas, Jr., M.D., director of CDC’s Division of STD Prevention. “STD screening and early treatment can prevent some of the most devastating effects of untreated STDs.”

CDC recommends annual chlamydia screening for sexually active women under the age of 25. CDC also recommends that girls and women between the ages of 11 and 26 who have not been vaccinated or who have not completed the full series of shots be fully vaccinated against HPV.

The study of STDs among teenage girls is one of several presented today at the 2008 National STD Prevention Conference that highlights the significant burden of STDs among girls and women, and identifies creative prevention strategies for reducing the toll of STDs in the United States.

Contraceptive services represent missed opportunities for STD screening, prevention

Two other studies featured at the conference point to missed opportunities for STD testing, and underscore that it is critical for STD screening to be included in comprehensive reproductive health services for young women.

A study by CDC’s Sherry L. Farr and colleagues found that while the majority of sexually active 15- to-24 year-old young women (82 percent) receive contraceptive or STD/HIV services, few receive both (39 percent). In addition, only 38 percent of a subset of young women who reported receiving contraceptive services associated with unprotected sex (e.g., pregnancy testing) also received STD/HIV counseling, testing or treatment, which indicates that many women at high risk are not receiving necessary prevention services.

A separate study, by CDC’s Shoshanna Handel and the New York City Department of Health and Mental Hygiene, examined STD screening rates among young women seeking emergency contraception, which would suggest recent unprotected sex. The study found that just 27 percent were screened for chlamydia or gonorrhea. A significant proportion of those women (12 percent) had a positive test result, highlighting the need for routine chlamydia and gonorrhea screening at emergency contraception visits.

Innovative programs provide models for effective STD prevention

Other research from the conference highlighted creative programs that are effectively screening and treating people with STDs, and identifying those most at risk.

A CDC-funded confidential chlamydia screening program in high school-based health clinics in California resulted in high rates of screening among those seeking contraceptive or STD services (range: 85-94 percent). It also revealed significantly higher infection rates among African-American women than white women (9.6 percent versus 1.7 percent).

A study by New York City health officials assessed the effectiveness of an express visit option, allowing patients at city clinics to be tested for STDs without a doctor’s exam. Comparing data before and after express visits were routinely offered, researchers found that the express visit option made it possible for an additional 4,588 tests to be performed, and increased STD diagnoses by 17 percent (2,617 versus 2,231).

# # #

DEPARTMENT OF HEALTH AND HUMAN SERVICES

On the Net:

• CDC: http://www.cdc.gov
• American Academy of Pediatrics: http://www.aap.org

FDA Names Permanent Director for CDER, Center for Drug Evaluation and Research

Commissioner of Food and Drugs Dr. Andrew C. von Eschenbach today announced, after a national search, the appointment of Janet Woodcock, M.D., as director of the agency's Center for Drug Evaluation and Research (CDER).

This appointment is of significance because CDER is charged with assuring that safe and effective drugs, including prescription, over-the-counter and generics, are available to Americans.

"Dr. Woodcock's outstanding scientific credentials and historical knowledge of the complexities involved in drug safety and regulation make her uniquely qualified to oversee, as well as modernize the techniques, tools, and methods used for evaluating the safety and effectiveness of drugs throughout the product life-cycle," said Dr. von Eschenbach.

A prominent FDA scientist and executive, Dr. Woodcock has received numerous awards, including a Presidential Rank Meritorious Executive Award, the American Medical Association's Nathan Davis Award, the American Association for Cancer Research Public Service Award, the National Organization for Rare Disorders Public Health Leadership Award, the Personalized Medicine Coalition's Award for Leadership in Personalized Medicine, the National Alliance for Hispanic Health's VIDA Award, and six Special Citations from FDA Commissioners.

Dr. Woodcock received her Doctor of Medicine from Northwestern Medical School and completed further training and held teaching appointments at the Pennsylvania State University and the University of California in San Francisco.

Throughout her career at the FDA, Dr. Woodcock has played an integral role in advancing the health of the American public. Under her strong leadership, the FDA launched the Critical Path Initiative designed to bridge the gap between basic scientific research and the medical product development process. This initiative called for a collaborative cross-sector effort to modernize the drug development process and has resulted in several prominent partnerships looking at a wide variety of scientific issues. Dr. Woodcock will continue to be involved in this initiative, as well as the emerging post-market surveillance collaborations with the private sector.

While serving as the agency's Deputy Commissioner and Chief Medical Officer, where she oversaw scientific and regulatory operations, Dr. Woodcock agreed to assume the role of Acting Director of CDER in October 2007. The recently announced Safety First program is one of the initiatives she has led since assuming the Center Director role in an acting capacity.

"Dr. Woodcock's exemplary service since October was confirmation of her being ideally suited to lead the Center during this crucial period following the passage of the Food and Drug Administration Amendments Act of 2007," noted Dr. von Eschenbach. "The agency is fully committed to implementing the drug safety programs laid out by this Act and meeting the goals set under the Prescription Drug User Fee program, which will help ensure that CDER has the additional resources that are needed to conduct these very complex and comprehensive reviews."

An internist and rheumatologist, Dr. Woodcock has previously held several other leadership positions in the agency, including Director, Office of Therapeutics Research and Review, and Acting Deputy Director, Center for Biologics Evaluation and Research, as well as Director of CDER.

"The FDA is truly blessed to have extraordinary public servants like Janet who are willing to use their skills and talents to guide the Centers in achieving the Agency's mission of protecting and promoting the public health," noted Dr. von Eschenbach.

tag: FDA, CDER, Commissioner of Food and Drugs,

Community Outreach and Education By CPSC, The U.S. Consumer Product Safety Commission

The New York Public Library to Provide Parents and Caregivers Lifesaving Information

NEW YORK CITY - Consumers are bombarded with news and information every day. Important safety information may be missed by parents due to the hectic pace of the day. Now, caregivers and consumers in New York City and across the country have an easy way to keep their families safe in their homes.

The U.S. Consumer Product Safety Commission (CPSC) offers free safety information to the public through its Neighborhood Safety Network (NSN), an initiative designed to assist local organizations in providing lifesaving information to underserved members of their community. The U.S. Department of Health and Human Services, a major health insurance company, fire departments, health clinics and numerous other organizations receive critical safety information from CPSC on poison prevention, carbon monoxide safety, bicycle safety and many other topics, which they provide to tens of thousands of parents and consumers across the country.

Today, The New York Public Library (NYPL) system announced that they have signed up to become a member of the NSN, joining a network of 5,200 grassroots organizations. In addition, CPSC encourages residents of New York City to join our “Drive To One Million” campaign – an initiative aimed at signing up one million consumers to receive free e-mail alerts on topics ranging from lead in toys to fire hazards with appliances to keeping babies and children safe at home.

At a press conference today at The New York Public Library’s Bronx Library Center, the U.S. Consumer Product Safety Commission (CPSC) Acting Chairman Nancy Nord, U.S. Congressman José Serrano, and the Bronx Library Center Chief Librarian Michael Alvarez urged parents, caregivers, and community leaders to sign up for the NSN and for CPSC’s free e-mail alerts. Both of these services can be accessed from www.cpsc.gov

“If you have a toy, a mattress, a toaster, or a crib, we have vital information for you. We want our safety messages to reach all consumers and we need your help,” said CPSC Acting Chairman Nord.

“I urge people to sign up to get alerts about product safety issues because it can help prevent accidents that could endanger children and adults,” said Congressman Serrano, whose Subcommittee oversees the budget of the CPSC. “I applaud the CPSC for trying to get the word out – both in English and Spanish – via traditional methods and new technologies. We all agree that we must step up efforts to protect consumers, and this is a vital program toward that end.”

“For the NYPL, joining CPSC in sharing safety information is a natural relationship. Libraries are information gateways for our communities,” said Michael Alvarez, Chief Librarian, Bronx Library Center. “We encourage users of the Bronx Library Center and other libraries to use our computer terminals to access this lifesaving information.”

The Library serves some 16 million patrons who come through its doors annually and another 25 million users internationally, who access collections and services through the NYPL website, www.nypl.org

To make product safety information available to an increasingly diverse community, CPSC is offering much of its safety information in Spanish. Consumers can receive instantaneous notice of product recalls by signing up at www.cpsc.gov

tag: NSN, CPSC, New York Public Library, Neighborhood Safety Network, poison prevention, carbon monoxide safety, bicycle safety,

Drugs In Your Drinking Water!

It looks like it or not, we are going to be loaded, in little dozes, of pharmaceuticals as we drink water. A vast array of pharmaceuticals — including antibiotics, anti-convulsants, mood stabilizers and sex hormones — have been found in the drinking water supplies of at least 41 million Americans, an Associated Press investigation shows.

The concentrations of these pharmaceuticals are tiny, measured in quantities of parts per billion or trillion, far below the levels of a medical dose. Also, utilities insist their water is safe. But the presence of so many prescription drugs — and over-the-counter medicines like acetaminophen and ibuprofen — in so much of our drinking water is heightening worries among scientists of long-term consequences to human health. Are we worried yet. Even if we do not die from these, our bodies reaction to these are unknown. It might be similar to our bodies getting used to antibiotics.

In the course of a five-month inquiry, the AP discovered that drugs have been detected in the drinking water supplies of 24 major metropolitan areas — from Southern California to Northern New Jersey, from Detroit to Louisville, Ky.

Water providers rarely disclose results of pharmaceutical screenings, unless pressed, the AP found. For example, the head of a group representing major California suppliers said the public "doesn't know how to interpret the information" and might be unduly alarmed. How good of them to look after us!

How do the drugs get into the water?

Find out in this AP Report

tag: Drugs in water, pharmaceuticals in water, drinking water

FDA Approves New Drug Application (NDA) for LEVOleucovorin

FDA has approved new drug application (NDA) for LEVOleucovorin, Spectrum’s first proprietary oncology drug
proprietary drug Levoleucovorin for injection (formerly known as ISO-Vorin, a novel folate analog, is the first new oncology drug approved by the FDA in 2008.

Proprietary Brand Names Submitted by Company Currently Under Review by FDA.

LEVOleucovorin Has Been Marketed with Success in Europe and Japan by Wyeth, Sanofi and Others.
Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI) today announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for Levoleucovorin for Injection. It is indicated after high-dose methotrexate therapy in patients with osteosarcoma, and to diminish the toxicity and counteract the effects of impaired methotrexate elimination or inadvertent overdose of folic acid antagonists. LEVOleucovorin is the only commercially available formulation comprised only of the pharmacologically active enantiomer of leucovorin (Levoleucovorin or (6S)-leucovorin). The Company currently expects its commercial launch by June 2008.
tag: FDA, Drug Approval, Spectrum Pharmaceuticals, Levoleucovorin, leucovorin, folate analog, oncology drug

Eli Lilly Terminates the AIR® Inhaled Insulin (AIR® Insulin) program With Alkermes

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alkermes, Inc. (NASDAQ: ALKS) announced that it has received a letter terminating the development and license agreement between Eli Lilly and Company (Lilly) and Alkermes dated April 1, 2001 thereby terminating the AIR^® Inhaled Insulin (AIR^® Insulin) program. The termination will become effective in 90 days. The termination of the agreement also results in the termination of the AIR Insulin supply agreement.

Alkermes is evaluating the impact of the termination of the AIR Insulin program on its business and will provide further details following a comprehensive business analysis.

tag: Health Business, Alkermes, Eli Lilly, AIR® Insulin, AIR® Inhaled Insulin

Chromium 101 in San Fernando Valley, Chromium investigation and cleanup work

Release date: 03/07/2008

Contact Information: Francisco Arcaute, 213-244-1815

SAN FRANCISCO – The U.S. Environmental Protection Agency along with the Los Angeles Regional Water Quality Control Board and the Calif. Department of Toxic Substances Control will host a workshop for the public on San Fernando Valley Chromium on Monday from 8 a.m. to 1 p.m. at the Glendale Civic Auditorium, 1401 North Verdugo Road in Glendale.

Local water purveyors, water system operators, elected officials and the public are invited to hear directly from the agencies the status of investigation and remediation activities to address chromium contamination in the San Fernando Valley.

"I'm pleased that our state and local partners have come together to inform the public of the past, ongoing and future activities related to groundwater protection,” said Wayne Nastri, the EPA’s Administrator for the Pacific Southwest region. “Cleaning up contamination in soil is key to protecting our groundwater resources from further chromium contamination.”

EPA has been active in groundwater cleanup efforts in the San Fernando Valley area since the early 1980s when solvent contamination was first discovered. Last year, EPA launched a focused investigation on chromium groundwater contamination within the Glendale Superfund site area that will lead to clean ups at chromium sources impacting Glendale area groundwater.

In 2007, EPA assumed the lead on 3 chromium source sites and completed a major cleanup at the All Metals Co. site at 264 W. Spazier Ave., in Burbank. The firm specialized in cadmium, copper, nickel, zinc, black-oxide and gold plating of parts.

Starting in 1998, EPA funded a 4-year study conducted by the Regional Water Quality Control Board of the extent of chromium contamination in the San Fernando Valley. This study provided the foundation for future chromium investigation and cleanup efforts.

Chromium is a metal found in natural deposits as ores containing other elements. The greatest use of chromium is in metal alloys such as stainless steel; protective coatings on metal; magnetic tapes; and pigments for paints, cement, paper, rubber, composition floor covering and other materials. Its soluble forms are used in wood preservatives.

For more information on Chromium please visit:
http://www.epa.gov/region09/waste/sfund/chromium/index.html or http://www.epa.gov/safewater/contaminants/dw_contamfs/chromium.html

tag: Toxic Substances Control, EPA, Water Quality Control, chromium contamination,

FDA Under Watch, By GOA, U.S. Government Accountability Office

Looks like FDA itself going to be under watch by GOA, the government's watchdog agency
is investigating whether the Food and Drug Administration's drug-review process cleared GlaxoSmithKline PLC's diabetes pill Avandia and Merck & Co. Inc. and Schering-Plough's cholesterol drug Vytorin without sufficient proof of their safety or effectiveness.

The Iowa Republican Sen. Charles Grassley said Tuesday the Government Accountability Office has agreed to study a much-debated method for approving drugs used to clear Avandia and Vytorin. The Senators investigation after recent studies suggested the drugs may not lower the risk of heart attack and artery-clogging plaque, as assumed by millions of patients and doctors.

"There's enough of a pattern of problematic drugs to ask for an independent review of how the FDA follows up on the effects of medicines that it's approved," said Grassley, in a statement.

FDA cleared Avandia because it helped control blood sugar, which many doctors believe decreases diabetics' risk of heart attack. But the agency came under fire last year when an analysis showed Avandia could actually increase heart attack risk.

The agency approved Vytorin, which combines Schering-Plough's Zetia with Merck's older cholesterol drug Zocor, based on its cholesterol-lowering capability. But a study released earlier this year showed Vytorin was no more effective at limiting plaque buildup in neck arteries than Zocor alone, which is now available as a low-cost generic.

Last month FDA cleared Genentech Inc.'s drug Avastin for use in breast cancer patients who have not taken other drugs. Agency reviewers based their decision on Avastin's ability to slow the spread of cancer. Previously FDA had approved drugs as a first-choice option for cancer patients if they extended, or improved the quality, of patients' lives.

Sen. Charles Grassley's Letter to GOA;

February 28, 2008

The Honorable David M. Walker
Comptroller General
U.S. Government Accountability Office
441 G St, NW
Washington, D.C. 20548

Dear Comptroller Walker:

The Food and Drug Administration (FDA) has approved several drugs that appear to have little to no effect in protecting lives and increasing health. For instance, FDA recently approved Genentech's cancer drug, Avastin, to treat breast cancer.[1] Genentech's studies showed that Avastin halted tumor growth, but that breast cancer patients did not live significantly longer than those that did not receive the drug. Surprisingly, FDA's own advisory panel argued against the approval over concerns that Avastin's benefits do not outweigh its toxic side effects.

Further, a study last year found that Avandia, which controls glucose levels, was associated with an increased risk of heart attack. And last month, Schering-Plough and Merck announced that Vytorin, which controls cholesterol levels, provided no benefit to cardiovascular outcomes.

In all three cases, these drugs were approved by FDA because they had an effect on surrogate endpoints (tumor growth for Avastin; glucose levels for Avandia; and cholesterol levels for Vytorin). However, none of these drugs were studied sufficiently to see if they added any benefit to the health and/or lifespan of the patient. Typically, such results can be found through phase IV trials.

Therefore, I request that the Government Accountability Office conduct an inquiry into the FDA's approval of drugs based on surrogate endpoints, including an examination of FDA's process to ensure that drugs approved on surrogate endpoints are both safe and effective. In particular, GAO's inquiry should include an analysis of the following:

C The number of drugs that were approved based on surrogate endpoints;
C The surrogate endpoints that FDA uses to approve drugs;
C For each of these drugs identified, the date each was approved and whether FDA required the companies to complete phase IV trials;

C For each of these phase IV trials, the date they were started and the date they were completed and/or are expected to be completed;
C Describe the tools that FDA has to compel companies to complete phase IV trials;
C Describe any actions that FDA has taken against companies for failing to complete phase IV trials or failing to complete trials in a timely manner; and
C Describe any additional powers that FDA may need to compel companies to complete phase IV trials, in the event the tools that FDA has presently are insufficient.

Thank you for your attention to this important matter.

Sincerely,
Charles E. Grassley
United States Senator
Ranking Member of the Committee on Finance

Parts Copyright 2008 The Associated Press.


tag: FDA, GOA, Sen. Charles Grassley, Vytorin, Zocor, Zetia, Avandia, Vytorin, Merck & Co, GlaxoSmithKline PLC, diabetes pill, cholesterol drug, Avastin, breast cancer

Sticky blood protein, Integrin beta3 yielding clues to autism-related deficits.

by Susanne Tranguch and Melissa Marino

Many children with autism have elevated blood levels of serotonin — a chemical with strong links to mood and anxiety. But what relevance this “hyperserotonemia” has for autism has remained a mystery.

New research by Vanderbilt University Medical Center investigators provides a physical basis for this phenomenon, which may have profound implications for the origin of some autism-associated deficits.

In an advance online publication in the Journal of Clinical Investigation, Ana Carneiro, Ph.D., and colleagues report that a well-known protein found in blood platelets, integrin beta3, physically associates with and regulates the serotonin transporter (SERT), a protein that controls serotonin availability.

Autism, a prevalent childhood disorder, involves deficits in language, social communication and prominent rigid-compulsive traits. Serotonin has long been suspected to play a role in autism since elevated blood serotonin and genetic variations in the SERT have been linked to autism.

Alterations in brain serotonin have also been associated with anxiety, depression and alcoholism; antidepressants that block SERT (known as SSRIs, or selective serotonin reuptake inhibitors) block SERT's ability to sweep synapses clean of serotonin.

Working in the lab of Randy Blakely, Ph.D., Carneiro was searching for proteins that interact with SERT that might contribute to disorders where serotonin signaling is altered.

“Levels of SERT in the brain are actually quite low, so we decided to see what progress we could make with peripheral cells that have much higher quantities,” said Blakely, director of the Vanderbilt Center for Molecular Neuroscience. “This took us to platelets.”

In platelets, SERTs accumulate serotonin produced in the gut. SSRIs or genetic deletion of SERT in animals prevents serotonin uptake in the platelet.

“Prior research had fingered the integrin beta3 gene as a determinant of blood serotonin levels and, independently, as a risk factor for autism,” Blakely said.

In the current study, Carneiro identified a large set of proteins that “stick” to SERT, presuming they might control SERT activity. One of these turned out to be integrin beta3.

Once they confirmed a physical relationship between the two proteins, Blakely's team investigated whether the interaction can change SERT activity. They found that cells lacking integrin beta3 exhibit reduced serotonin uptake and that integrin beta3 activation or a human integrin beta3 mutation greatly enhances serotonin uptake.

“We found that integrin beta3 can put the serotonin transporter into high gear,” said Blakely. Notably, Edwin Cook, M.D., at the University of Illinois at Chicago and a co-author on the study, had shown that the same integrin beta3 mutation that elevates SERT activity also predicts elevated blood serotonin.

“Most investigators studying this integrin beta3 mutation have focused on how its high activity state changes platelet clotting and never looked at its impact on serotonin levels or SERT function,” explained Carneiro. “Now they have a reason to.”

“We don't think the platelet itself contributes to autism,” said Blakely, “but rather we believe that the brain's serotonin transporter may be controlled by integrin proteins in a very similar manner.”

Carneiro and Blakely believe that too much SERT activity imposed by abnormal integrin interactions could restrict availability of serotonin in the brain during development, as well as in the adult.

“What is even more striking is that this is the second time we have found elevated SERT activity associated with autism,” said Blakely. In a 2005 study, Blakely and Vanderbilt collaborator James Sutcliffe, Ph.D., identified mutations in the SERT gene that triggered elevated SERT activity.

Carneiro is now hot on the trail of integrin interactions with brain SERT as well as engineering mice that express human integrin beta3 mutations.

At a February Keystone Conference, Blakely described preliminary studies with mice that his lab has engineered to express hyperactive SERT mutations. “Together, these new animal models offer an unprecedented opportunity to peel away the complexity of autism and possibly develop new therapies,” he said.

This research also may uncover new ways of treating depression.

“Current antidepressant mechanisms still essentially work in the same way they did 25 years ago — by targeting transporter uptake of neurotransmitter directly,” Carneiro said. “Now we may have a completely new way to go about it. “

These new studies represent an early success of Vanderbilt's recently established Silvio O. Conte Center for Neuroscience Research, an NIMH-sponsored program designed to investigate the genes and proteins that control serotonin signaling during development and in the adult, Blakely noted.

The research was also supported by the National Alliance for Research on Schizophrenia and Depression (NARSAD).

The Reporter, Vanderbilt University Medical Center

tag: autism, serotonin, Vanderbilt University Medical Center, hyperserotonemia, blood platelets, integrin beta3, SERT, SSRIs, NARSAD

Eli Lilly distorted the science and downplayed the health risks of its schizophrenia drug Zyprexa to make more money, EX-FDA Official.

ADN is reporting that a retired medical officer with the federal Food and Drug Administration testified Friday that drug maker Eli Lilly distorted the science and downplayed the health risks of its schizophrenia drug Zyprexa to make more money.
John Gueriguian, who worked 20 years for the FDA and is now a consultant, was on the stand in Anchorage Superior Court all day Friday as an expert witness for the state of Alaska.
The state is suing Eli Lilly and Co. to recover costs to its Medicaid system for what it contends are serious health problems, including weight gain and diabetes, caused by Zyprexa. The state says the company failed to warn of troubles because it counted on Zyprexa to become its next big moneymaker.
Global sales of Zyprexa approached $4.8 billion last year.

At the FDA, Gueriguian worked for the division that oversaw diabetic drugs, not psychiatric medication, so he wasn't directly involved in oversight of Zyprexa. Lawyers working for the state hired him to analyze Lilly documents and e-mails and said it's impossible to get current FDA employees to testify.

If Lilly could show that diabetes was common for this class of drugs, then it would no longer be a special problem for Zyprexa, said a Nov. 28, 2001, company document.

Continue reading at Anchorage Daily News.

tag: Zyprexa, Eli Lilly, schizophrenia drug, Anchorage Superior Court,

Autism and Vaccines, Plus A Autism Case Settled!

Another article I read today about vaccines, autism and injuries caused by vaccines, makes me think that we will be hearing a lot more about the subject. Since a settlement — reached last fall in a federal compensation court for people injured by vaccines, but disclosed only in recent days, is a long-overdue government recognition that vaccinations can cause autism.
WASHINGTON — Study after study has failed to show any link between vaccines and autism, but many parents of autistic children remain unconvinced. For the skeptics, the case of 9-year-old Hannah Poling shows that they have been right along.
The government has conceded that vaccines may have hurt Hannah, and it has agreed to pay her family for her care. Advocates say the settlement — reached last fall in a federal compensation court for people injured by vaccines, but disclosed only in recent days — is a long-overdue government recognition that vaccinations can cause autism.

Mr. Gilmore has filed his own claim that his son became autistic as a result of vaccinations.
Government officials say they have made no such concession.
“Let me be very clear that the government has made absolutely no statement indicating that vaccines are a cause of autism,” Dr. Julie L. Gerberding, director of the Centers for Disease Control and Prevention, said Thursday. “That is a complete mischaracterization of the findings of the case and a complete mischaracterization of any of the science that we have at our disposal today.”

Hannah, of Athens, Ga., was 19 months old and developing normally in 2000 when she received five shots against nine infectious diseases. Two days later, she developed a fever, cried inconsolably and refused to walk. Over the next seven months she spiraled downward, and in 2001 she was given a diagnosis of autism.

Hannah’s father, Dr. Jon Poling, was a neurology resident at Johns Hopkins Hospital at the time, and she underwent an intensive series of tests that found a disorder in her mitochondria, the energy factories of the cells.

The disease control centers, the Food and Drug Administration, the Institute of Medicine, the World Health Organization and the American Academy of Pediatrics have all largely dismissed the notion that thimerosal causes or contributes to autism.
tag: autism, vaccine, Hannah of Athens, FDA, the Institute of Medicine, WHO, AAP, thimerosal

Heparin Trouble In Germany Too!

New York Times is reporting that Germany has recalled and issued warnings on heparin that were made with ingredients from China.

In the United States, there are 19 deaths related heparin and the US manufacturer Baxter took it's sweet time recalling heparin, since December 2007. We covered it since initial FDA warning and heparin recall in December 2007 to the latest heparin news that there were deaths associated with heparin. But news continue to fill the media waves.

FRANKFURT — The German authorities said Friday that they had asked all German producers of the blood thinner heparin to check whether their ingredients came from China, after allergic reactions to the drug there were linked to two Chinese suppliers.

In cases where China did supply the raw ingredient, manufacturers were asked to test for any irregularities. The German authorities recalled the suspect heparin on Wednesday after receiving reports of allergic reactions in about 80 patients.

The suspect heparin in the United States was made by Baxter International, with ingredients from a Chinese company called Changzhou SPL. The discovery that the ingredients for the German-made heparin came from two different Chinese plants has led investigators to suspect that the problem may lie farther back in the supply chain.

tag: FDA Recall, drug recall, Changzhou SPL, heparin, HEP-LOCK products, Baxter International recall,

Working Smoke Alarms Are Key to Surviving Home Fires,

FOR IMMEDIATE RELEASE March 6, 2008 Release #08-211

CPSC Recall Hotline: (800) 638-2772 CPSC Media Contact: (301) 504-7800

CPSC Daylight Saving Time Alert: Working Smoke Alarms Are Key to Surviving Home Fires

WASHINGTON, D. C. – Smoke alarms are proven life savers. There are more than 300,000 residential fires every year, so when there is a fire, smoke alarms buy families valuable escape time.

Unfortunately, about two-thirds of fire deaths take place in homes with no smoke alarms or with non-working smoke alarms. The most common reasons why alarms did not work were missing, disconnected, or dead batteries. Consumers need to make sure that they have a working smoke alarm.

For better warning of fire, consumers should install smoke alarms on every level of the home, outside sleeping areas, and inside bedrooms. Replace batteries annually, and test the smoke alarms monthly. A good time to remember to replace batteries is when turning clocks ahead for daylight saving time on Sunday, March 9.

When shopping for smoke alarms, consumers should be aware of the two different types of smoke alarms: ionization and photoelectric. While both types are effective smoke sensors, ionization type detectors respond quickly to flaming fires, while photoelectric type detectors respond sooner to smoldering fires. Since consumers can’t predict what types of fires might break out, CPSC staff recommends (pdf) installing both ionization and photoelectric type smoke alarms (pdf) throughout the home for the best warning of a fire. This recommendation is also supported by the United States Fire Administration, the National Fire Protection Association, Underwriters Laboratories, and by research conducted by the National Institute for Standards and Technology. There are also dual sensor smoke alarms that have both ionization and photoelectric sensors in one unit.

Consumers should also consider interconnected smoke alarms. Interconnected alarms are connected to each other by a hard wire or by wireless technology. If one alarm is triggered, all interconnected alarms in the home sound, alerting consumers to the fire earlier.

Many residential fires are preventable. CPSC recommends consumers follow these safety steps:

	Never leave cooking equipment unattended.
	Have a professional inspect home heating, cooling, and water appliances annually.
	Inspect electrical cords for signs of wear, cracks, or age, and keep lighting away from combustibles.
	Use caution with candles, lighters, matches, and smoking materials near upholstered furniture, mattresses, and bedding. Keep matches and lighters out of reach of young children.
	Have a fire escape plan (about 14 mb, Quicktime version 7 or greater format) and practice it so family members know what to do and where to meet if there’s a fire in the home. Children and the elderly may sleep through or not react to the sound of the smoke alarm, so parents and caregivers should adjust their fire escape plan to help them escape the house in the event of a fire.

For more information, also visit www.FireSafety.gov, for fire safety information from CPSC and other federal agencies.

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Send the link for this page to a friend! The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of serious injury or death from more than 15,000 types of consumer products under the agency's jurisdiction. Deaths, injuries and property damage from consumer product incidents cost the nation more than $800 billion annually. The CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical, or mechanical hazard. The CPSC's work to ensure the safety of consumer products - such as toys, cribs, power tools, cigarette lighters, and household chemicals - contributed significantly to the decline in the rate of deaths and injuries associated with consumer products over the past 30 years.

To report a dangerous product or a product-related injury, call CPSC's hotline at (800) 638-2772 or CPSC's teletypewriter at (800) 638-8270, or visit CPSC's web site at www.cpsc.gov/talk.html. To join a CPSC email subscription list, please go to https://www.cpsc.gov/cpsclist.aspx. Consumers can obtain this release and recall information at CPSC's Web site at www.cpsc.gov.

tag: Smoke Alarms, Home safety, ionization smoke alarms, photoelectric smoke alarms, CPSC Advisory, fire escape plan, Fire Alarm,

Recallr: CPSC Consumer Products Recalls For March 06th 2008.

Recallr: CPSC Consumer Products Recalls For March 06th 2008.
Wow.
tag: CPSC recall, Hamilton Beach® and Proctor-Silex® Toaster recall, Strike Force™ Portable Air Compressor recall, Pier 1 Imports Silver Square Tealight Candle Holder recall, QVC Inc Electric Contact Grill recall, Infantino Lamb Grabby Rattles recall, Rebelette International Trading Corp Girls’ Hooded Sweatshirt recall, Kawasaki KLX140 Off-Road Motorcycle Recall, LDR 1200 Series Gas Connector recall, "Outlaw IRS" ATV Recall,

FDA updates safety information for long acting beta agonists (LABA).

Advair Diskus, Advair HFA, Brovana, Foradil, Serevent Diskus, and Symbicort Information
(Long Acting Beta Agonists)

On November 18, 2005, FDA alerted health care professionals and patients that several long-acting bronchodilator medicines have been associated with possible increased risk of worsening wheezing (bronchospasm) in some people, and requested that manufacturers update warnings in their existing product labeling. This information has now been included in updated labeling.

On March 2, 2006, FDA approved new safety labeling and Medication Guides for patients for Serevent Diskus (salmeterol xinafoate) and Advair Diskus (fluticasone propionate; salmeterol xinafoate). On June 19, 2006, FDA approved new safety labeling and a Medication Guide for patients for Foradil (formoterol fumarate), and also approved Advair HFA. Symbicort Inhalation Aerosol was approved on July 21, 2006.

March 5, 2008 Update: On November 28, 2007, a Pediatric Advisory Committee (PAC) meeting was held. At this meeting, FDA raised concerns about the safety of long-acting beta2 adrenergic agonists (LABAs) in pediatric patients with asthma. The PAC has agreed with an FDA recommendation to continue assessment of the risks of LABAs and seek advice from a future advisory committee (http://www.fda.gov/ohrms/dockets/ac/oc07.htm#pac).

In January, 2008 FDA requested manufacturers of Advair Diskus, Advair HFA, Brovana Inhalation Solution, Foradil Aerolizer, Perforomist Inhalation Solution, Serevent Diskus, and Symbicort Inhalation Aerosol to provide information regarding controlled clinical studies conducted with these products in order to further evaluate the safety of LABAs when treating asthma.

The manufacturers have indicated it will take several months to submit the requested information. Following review of this information, FDA plans to bring the issue of the benefit/risk assessment of LABAs in adults and children to an advisory committee in the fall or winter of 2008.

Labels and Medication Guides

• Advair Diskus Label (updated 3/2/2006)
• Advair Diskus Medication Guide for Patients
  
• Advair HFA Label (6/8/2006)
• Advair HFA Medication Guide for Patients
  
• Brovana Label (10/6/2006)
• Brovana Medication Guide for Patients

• Foradil Aerolizer Label (updated 6/19/2006)
• Foradil Aerolizer Medication Guide for Patients
  
• Serevent Diskus Label (updated 3/2/2006)
• Serevent Diskus Medication Guide for Patients
  
  
• Symbicort Inhalation Aerosol Label
• Symbicort Medication Guide for Patients

Patient Information Sheets

• Fluticasone propionate; Salmeterol xinafoate (marketed as Advair Diskus) [HTML] [PDF] (updated 5/15/2006)
• Fluticasone propionate; Salmeterol xinafoate (marketed as Advair HFA) [HTML] [PDF] (posted 7/5/2006)
• Formoterol fumarate (marketed as Foradil Aerolizer) [HTML] [PDF] (updated 7/5/2006)
• Salmeterol xinafoate (marketed as Serevent Diskus) [HTML] [PDF] (updated 5/15/2006)

Other Information

• Historical Information

tag: FDA Alert, Advair Diskus, Advair HFA, Brovana, Foradil, Serevent Diskus, Symbicort, wheezing, bronchospasm, salmeterol xinafoate, fluticasone propionate, salmeterol xinafoate, Medication Guide, LABA

Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables

This is only a tip of an ice berg of an article/document available at FDA/CFSAN. In fact Only the introduction is available here. But if you are anyway connected to processing of Fresh-cut Fruits and Vegetables, (You are because, I am sure you eat them!) the article will educate you to no end. I learned about few facts that I did not know about food processing and looking for better products.

Guidance for Industry By Center For Food Safety And Applied Nutrition (CFSAN).

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate telephone number listed on the title page of this guidance.

I. Introduction

The Federal Government provides advice on healthful eating, including consuming a diet rich in a variety of fruits and vegetables, through the Dietary Guidelines for Americans and the related MyPyramid food guidance system (Ref. 1, 2). In response, per capita consumption data show that Americans are eating more fresh produce (Ref. 3). With $12 billion in annual sales in the past few years (Ref. 4), the fresh-cut sector of the produce industry is its fastest growing segment. As the fresh-cut produce market continues to grow, the processors of such produce are faced with the challenge of processing an increasing variety and volume of products in a manner that ensures the safety of this produce. From 1996 to 2006, seventy-two foodborne illness outbreaks were associated with the consumption of fresh produce. Of these produce related outbreaks, 25 percent (18 outbreaks) implicated fresh-cut produce (Ref. 5). Many factors may play a role in the incidence and reporting of foodborne illness outbreaks that implicate fresh produce, such as an aging population that is susceptible to foodborne illness, an increase in global trade, a more complex supply chain, improved surveillance and detection of foodborne illness, improvements in epidemiological investigation, and increasingly better methods to identify pathogens (Refs. 6 thru 12).

Processing fresh produce into fresh-cut products increases the risk of bacterial growth and contamination by breaking the natural exterior barrier of the produce (Ref. 6).The release of plant cellular fluids when produce is chopped or shredded provides a nutritive medium in which pathogens, if present, can survive or grow (Ref. 6). Thus, if pathogens are present when the surface integrity of the fruit or vegetable is broken, pathogen growth can occur and contamination may spread. The processing of fresh produce without proper sanitation procedures in the processing environment increases the potential for contamination by pathogens (see Appendix B, "Foodborne Pathogens Associated with Fresh Fruits and Vegetables."). In addition, the degree of handling and product mixing common to many fresh-cut processing operations can provide opportunities for contamination and for spreading contamination through a large volume of product. The potential for pathogens to survive or grow is increased by the high moisture and nutrient content of fresh-cut fruits and vegetables, the absence of a lethal process (e.g., heat) during production to eliminate pathogens, and the potential for temperature abuse during processing, storage, transport, and retail display (Ref. 6). Importantly, however, fresh-cut produce processing has the capability to reduce the risk of contamination by placing the preparation of fresh-cut produce in a controlled, sanitary facility.

This guidance is intended for all fresh-cut produce processing firms, both domestic firms and firms importing or offering fresh-cut product for import into the U.S., to enhance the safety of fresh-cut produce by minimizing the microbial food safety hazards. This guidance does not set binding requirements or identify all possible preventive measures to minimize microbial food safety hazards. We recommend that each fresh-cut produce processor assess the recommendations in this guidance and then tailor its food safety practices to the processor's particular operation. Alternative approaches that minimize microbial food safety hazards may be used so long as they are consistent with applicable laws and regulations.

This guidance primarily addresses microbiological hazards and appropriate control measures for such hazards. However, some chapters in the guidance discuss physical and chemical hazards.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.An Example of Product/Personnel Flow Patterns in a Fresh-cut Processing Plant

tag: FDA, CFSAN, Fresh-cut Fruits and Vegetables, healthful eating, fresh produce, foodborne illness, epidemiological investigation, Food Processing,

Tamoxifen, Soy, and Lifestyle Factors in Asian American Women With Breast Cancer

Diet/Drug Interactions – A collaboration between NCTR (National Center For Toxicological Research) and the University of Southern California has shown that circulating levels of tamoxifen and its therapeutically active metabolites in Asian women (n=380) undergoing therapy for breast cancer was not affected by dietary soy intake. By comparison, this study also showed that age/menopausal status, body weight, and use of hypertensive medications, particularly diuretics, significantly influenced the circulating levels of tamoxifen and its metabolites.

However, approximately one-third of patients with estrogen-receptor positive tumors do not ever respond to tamoxifen therapy, and patients eventually can become resistant to the therapeutic benefits of tamoxifen treatment. Future studies that include breast cancer survival and relapse assessments will be needed to determine whether soy isoflavones can affect the overall efficacy of tamoxifen chemotherapy.

These findings recently were published by Wu et al. in Journal of Clinical Oncology published 2007; Vol 25; 3024-3030. For further information, contact Dr. Tom Flammang or Dr. Dan Doerge at NCTR.

tag: breast cancer, NCTR, tamoxifen, dietary soy, Clinical Oncology

FDA Warns six U.S. companies and foreign individual for marketing unapproved and misbranded Drugs Claming To Treat STDs.

FOR IMMEDIATE RELEASE March 6, 2008

Media Inquiries: Rita Chappelle, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Warns Companies Importing and Marketing Drugs Over the Internet that Fraudulently Claim to Prevent and Treat STDs

The U.S. Food and Drug Administration today issued Warning Letters to six U.S. companies and one foreign individual for marketing unapproved and misbranded drugs over the Internet to U.S. consumers for the prevention and treatment of sexually transmitted diseases (STDs).

Some of these products, directed at U.S. consumers, falsely claim to have "FDA Approval" and some claim to be "more effective" than conventional medicine. The products are sold as Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus. Consumers who are currently using these products should stop their use immediately and consult their health care professional if they have experienced any adverse effects that they suspect are related to the use of any of these products.

"The products pose a serious health threat to unsuspecting consumers who don’t know that these products are not FDA approved and have not been proven safe or effective," said Janet Woodcock, M.D., deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the FDA’s Center for Drug Evaluation and Research. "STDs are very serious diseases and these products give consumers a false sense of security that they are protected from STDs."

The products claim to prevent or treat a variety of STDs, including Herpes, Chlamydia, Human Papilloma Virus, cervical dysplasia, and HIV/AIDS. The FDA considers these U.S. and imported products to be unapproved new drugs being marketed in violation of the Federal Food, Drug and Cosmetic Act. They are also misbranded under the law because they lack proper directions for use by consumers. In addition, some of the products are misbranded because they make false and misleading claims.

Examples of claims that these products make include "Treatment Kills all Herpes Viruses WITHOUT having to use conventional drugs or medications," "Greatest STD Protection Without Condoms," (SlicPlus) and "The active ingredient in our product is FDA certified to destroy 99.9992 percent of all pathogenic organisms [ie] Chlamydia" (OXi-MED).

The Warning Letters inform the companies that failure to properly resolve violations of the law may cause them to face further enforcement action that can include seizure of illegal products, injunction, and possible criminal prosecution.

Issuing these Warning Letters is part of the FDA’s ongoing campaign against fraudulent products marketed on the Internet for serious and life-threatening diseases. The agency also works to educate consumers about the risks and dangers that exist from buying unsafe products.

Consumers and health care professionals should notify the FDA of any complaints or problems associated with these products. These reports may be made to MedWatch, the FDA’s voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm.

To view the letters,
http://www.fda.gov/foi/warning_letters/s6680c.htm - Aviralex Int.

http://www.fda.gov/foi/warning_letters/s6681c.htm - Aidance Skincare

http://www.fda.gov/foi/warning_letters/s6682c.htm - Health-science-report

http://www.fda.gov/foi/warning_letters/s6683c.htm - NeumaLife

http://www.fda.gov/foi/warning_letters/s6684c.htm - IMULUX, LLC

http://www.fda.gov/foi/warning_letters/s6685c.htm - Saferex Laboratories

http://www.fda.gov/foi/warning_letters/s6686c.htm - McKinnon, Blair

tag: FDA, fda warning, sexually transmitted diseases, STDs, Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, SlicPlus, Herpes, Chlamydia, Human Papilloma Virus, cervical dysplasia, HIV/AIDS,

Aunt Jemima Pancake & Waffle Mix Recalled By The Quaker Oats Co.

March 4, 2008 – The Quaker Oats Co. announced the products in the recall are a small quantity of Aunt Jemima Pancake & Waffle Mix: Original, Original Complete and Buttermilk Complete, which may have potential salmonella contamination. No other Aunt Jemima, frozen Aunt Jemima or Quaker products are affected.

The products, sold in 2 pound and 5 pound boxes with Best Before dates of FEB 08 09 H through FEB 16 09 H stamped on the top, contain the following UPC codes:

• 30000 43272: Aunt Jemima Buttermilk Complete, 5 lb.
• 30000 05040: Aunt Jemima Original, 2 lb.
• 30000 05070: Aunt Jemima Original Complete, 2 lb.
• 30000 05300: Aunt Jemima Buttermilk Complete, 2 lb.

Salmonella is a food borne illness that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain.

Recallr: The Quaker Oats Co. Recalls Aunt Jemima Pancake & Waffle Mix

tag: Aunt Jemima Pancake & Waffle Mix Recall, The Quaker Oats Co. Recall, salmonella contamination

Recallr: Gourmet Boutique, L.L.C., Recalls Meat and Poultry Products for Possible Listeria Contamination

Gourmet Boutique, L.L.C., a Jamaica, N.Y., firm, is voluntarily recalling approximately 6,970 pounds of meat and poultry products that may be contaminated with Listeria monocytogenes, the U.S. Department of Agriculture's Food Safety and Inspection Service announced today.
The recalled products bear the production code of "GBD 08058" on the package. The meat and poultry products were produced on Feb. 26 and 27, 2008, and were sent to retail establishments in Connecticut, Florida, Georgia, Massachusetts, Minnesota, New Jersey, New York, Pennsylvania, South Carolina and Wisconsin, and distribution centers in New York.

The problem was discovered through FSIS microbiological sampling. FSIS has received no reports of illnesses associated with consumption of this product.
Recallr: Gourmet Boutique, L.L.C., Recalls Meat and Poultry Products for Possible Listeria Contamination

tag: Meat and Poultry Products recall, Food recall, Gourmet Boutique, L.L.C. Recall, Listeria monocytogenes,

Fake Doctors Notes, May Make That Time Off Easy

An Internet marketer from Saint Paul, MN, has found a steady yet controversial second income - selling fake doctor’s notes on the Internet. BestFakeDoctorNotes.com, offers fabricated doctor’s notes for ‘entertainment use only.’

The site, which has been online since November 2007, portrays itself as a colorful sales letter from a fictional, sunglasses-wearing doctor named Dr. E.Z. Streat. For a small price, ($14.97) the “doctor” will instantly email you the twelve authentic looking doctor notes. Once received, the notes can be edited and signed.

The site isn’t the first to sell fake doctor notes on the internet. Throughout the past year several sites have sprung up for business. Marquisi claims to stand out from the pack by creating higher quality notes of better value. The medical logos and graphics, he explains, are what make his notes look legitimate.

Many consider using fake doctor notes to be unethical, however Marquis feels differently.

“I simply saw a demand on the internet and created a product to fulfill that demand. My products are for entertainment use only, but if someone chooses to use them in other ways, that is their decision. I do not encourage illegal use of my products,” Marquisi states.

The website has a slightly different statement. Early in the sales page, “Dr. E.Z. Streat” explains that Americans are overworked, overstressed, and simply “Need a Damn Break.”

tag: Fake Doctors Notes, Best Fake Doctor Notes, Dr. E.Z. Streat, Craigslist marketing guide.Chiropractor, Cardiologist, Gynecologist

The U.S. Coast Guard Updates Carbon Monoxide Status For Recreational Boaters

The Coast Guard has conducted an investigation to determine what carbon monoxide (CO) detection devices are available to recreational boaters, such that, when installed and activated could reduce the risk of being exposed to high levels of CO -THAT SILENT KILLER. A variety of technologies is available for detecting the presence of CO on boats and should be considered by recreational boaters to reduce their risk of injury or death while boating.

CO-DetectorForMarineUseInformation11Feb2008.pdf
tag: recreational boating, U.S. Coast Guard, carbon monoxide (CO) detection, carbon monoxide,

Two More Nevada Clinics Tied To hepatitis exposure scare Closed

The Henderson and North Las Vegas offices of a clinic at the center of a massive health alert were shut down by officials in the cities Tuesday.

Citing the public health emergency, officials in both cities ordered the Gastroenterology Center of Nevada to cease operations, effectively shuttering all but one of the group's facilities in the valley.

A Las Vegas office of the Gastroenterology Center of Nevada, 3150 Tenaya Way, remained open as of late afternoon Tuesday.

Clark County officials on Monday shut down three clinics owned by the medical group. Three days earlier, Las Vegas officials closed an endoscopy center on Shadow Lane where investigators found that staff reused syringes, contaminating vials of medication and infecting six people with hepatitis C.
Health officials have sent 40,000 letters to that clinic's patients, urging them to get tested for hepatitis C and B and HIV, the virus that causes AIDS.

Henderson's action came after a city inspector was locked out of the medical group's office at 2610 W. Horizon Ridge Parkway, Suite 105.
City spokeswoman Cindy Herman said the inspector was allowed inside at first, but when he went out to his vehicle to get some business cards and other information, the office's front door was bolted shut behind him.

The city immediately moved to suspend the office's business license after that, Herman said. Within hours of Henderson's action, North Las Vegas officials ordered a similar office at 1815 E. Lake Mead Blvd., Suite 207, to close its doors.

The cease and desist order, signed by city Business License Manager Lana Hammond, said in part, "Your demonstrated willful failure to observe long accepted and mandated medical sanitary protocols jeopardizes the health and safety of all citizens of the City of North Las Vegas."
Read More at Las Vegas Review-Journal.
Review-Journal writer Jennifer Robison contributed to this report. Contact reporter Henry Brean at hbrean@reviewjournal.com or (702) 383-0350. Contact reporter Lynnette Curtis at lcurtis@reviewjournal.com or (702) 383-0285.


Technorati Tags: hepatitis C, hepatitis B, HIV, hepatitis exposure, Las Vegas hepatitis scare

CDC Warns On Safty Problems At Clinics, Arising From Nevada Hepatitis C Case.

WASHINGTON (AP) — An outbreak of hepatitis C at a Nevada clinic may represent "the tip of an iceberg" of safety problems at clinics around the country, according to the head of the Centers for Disease Control and Prevention.

The city of Las Vegas shut down the Endoscopy Center of Southern Nevada last Friday after state health officials determined that six patients had contracted hepatitis C because of unsafe practices including clinic staff reusing syringes and vials. Nevada health officials are trying to contact about 40,000 patients who received anesthesia by injection at the clinic between March 2004 and Jan. 11 to urge them to get tested for hepatitis C, hepatitis B and HIV.

Senate Majority Leader Harry Reid, D-Nev., met Monday with CDC head Dr. Julie Gerberding, and on a media conference call after their meeting both strongly condemned practices at the clinic.

Health care accreditors "would consider this a patient safety error that falls into the category of a 'never event,' meaning this should never happen in contemporary health care organizations," said Gerberding.

"This is the largest number of patients that have ever been contacted for a blood exposure in a health-care setting. But unfortunately we have seen other large-scale situations where similar practices have led to patient exposures," Gerberding said.

"Our concern is that this could represent the tip of an iceberg and we need to be much more aggressive about alerting clinicians about how improper this practice is," she said, "but also continuing to invest in our ability to detect these needles in a haystack at the state level so we recognize when there has been a bad practice and patients can be alerted and tested."

Reid said he would work with Gerberding to try to get the CDC more resources in an emergency spending bill Congress is to take up in April.

State health officials said they weren't sure how many of the 40,000 patients they'd been able to contact since making the risk public last Wednesday. At least initially they didn't have correct addresses for 1,400, officials said.

The head of the clinic, Dr. Dipak Desai, purchased space for an open letter in the Las Vegas Review-Journal on Sunday in which he expressed "my deepest sympathy to all our patients and their families for the fear and uncertainty that naturally arises from this situation."

Desai offered no apology but said a foundation was being set up to cover testing costs. He also defended practices at his clinic, which performs colonoscopies.

"The evidence does not support that syringes or needles were ever reused from patient to patient at the center," Desai wrote.

A spokeswoman, Nancy Katz, declined Monday to comment further.

The Clark County district attorney is investigating, as are various health agencies, including the Nevada State Board of Nursing. Several lawsuits already have been filed and a hearing is scheduled for Thursday before a Nevada legislative committee.

It may never be known how many people contracted hepatitis C because of unsafe practices at the endoscopy center, state health officials said. Brian Labus, head epidemiologist of the Southern Nevada Health District, said that because 4 percent of the population has hepatitis C, he expects to get numerous positive results after the at-risk clinic patients are tested and it may be impossible to determine which of those were infected at the clinic.

Of the six cases that health officials did trace to the clinic, five of them happened on the same day and genetic testing was used to make the connection, Labus said.

Hepatitis C can cause fatal liver disease as well jaundice and fatigue, but 80 percent of people infected show no symptoms. Hepatitis B is a more rare and serious disease that attacks the liver.

Meanwhile, state health officials are still looking at a second clinic with connections to the first, called Desert Shadow Endoscopy Center. At Desert Shadow, officials had been found to reuse anesthetic vials but not syringes and so far no patients have been notified of potential risk. That determination could still be made, said Lisa Jones, head of the Nevada State Health Division's bureau of licensure and certification.

tag: CDC, hepatitis C, Nevada clinichepatitis B, HIV, Needle Reusage,

FDA's Q & A on Chattem, Inc. “Icy Hot Heat Therapy Air Activated Heat”

FDA has provided Questions and Answers session on recent recall Of “Icy Hot Heat Therapy Air Activated Heat”

What is “Icy Hot Heat Therapy Air Activated Heat”?

Icy Hot Heat Therapy Air Activated Heat is an adhesive patch that generates heat. The patch comes in a red sealed plastic pouch. Once the pouch is opened and the patch is exposed to air, the chemicals contained in the patch activate to produce heat. It is then applied to body surfaces to relieve muscle and joint pain associated with arthritis, backache, muscle strains and sprains.

What is the problem with Icy Hot Heat Therapy Air Activated Heat products?

Chattem, Inc. chose to recall their Icy Hot Heat Therapy products because they received consumer reports of first, second and third degree burns as well as skin irritation and skin removal resulting from the use of the Icy Hot Heat Therapy Air Activated Heat patch. As part of FDA's recall classification process, we will be reviewing the firm's root-cause analysis on what caused the burns.

What is the difference between first, second and third degree burns?

The type of burn is determined by how deeply it penetrates into the skin. There are two main layers of skin, and the degree of burn is based on how each layer is affected. First degree burns are the least severe and third degree burns are the deepest or most severe.

First Degree Burns: Means the top layer of skin (the epidermis) is damaged but not destroyed and turns bright pink or very red. Pain from first degree burns ranges from mild to extreme. No skin comes off and there are no blisters. Mild sunburns are a good example of first degree burns.

Second Degree Burns: Means burn damage has gone through the top layer (the epidermis) and into the 2nd layer of skin (the dermis). The top layer of skin is destroyed and may slide off or blister. Blisters are the first sign of a second degree burn. The wound appears red or pink and moist. Second degree burns are the most painful kind of burn.

Third Degree Burns: Means the burn has destroyed both the first and second (epidermis and dermis) layers of the skin. The exposed wound appears white, gray, yellow, brown or black and is usually dry. There may be little or no pain or the area may feel numb because of nerve damage.

When were the Icy Hot Heat Therapy Air Activated Heat patches produced and sold?

The firm issued a press release, dated February 8, 2008, for their voluntary recall involving 2.3 million Icy Hot Heat Therapy Air Activated Heat patches distributed in the United State since December 2006. The products were manufactured between December 2006 and February 2008 and sold over the counter through food, drug and mass merchandisers. You can find a listing of retailers on Chattem, Inc.’s website at http://www.chattem.com/wheretobuy/icy.asp.

What products are affected by the recall?

All lots and all sizes of the following Icy Hot Heat Therapy products are affected by this recall:

• Icy Hot Heat Therapy Air Activated Heat - Back
• Icy Hot Heat Therapy Air Activated Heat - Arm, Neck, and Leg
• Icy Hot Heat Therapy Air Activated Heat - Arm, Neck, and Leg in single-use “samples” that were included on a limited promotional basis in yellow and red cartons of 3 oz. Aspercreme Pain Relieving Crème. The samples were distinct and stand-alone products, clearly labeled as "Icy Hot Heat Therapy Air Activated Heat." This recall only involves the above listed Icy Hot Heat Therapy products and does not involve any other Icy Hot products such as the medicated patch, cream, or balm/stick that also use the “Icy Hot” name.

If the product was removed from the original carton, what does it look like?

The product inside the carton is in a red plastic pouch that says Icy Hot Heat Therapy and either Back or Arm/Neck and Leg. If you are unsure you have an affected product, you should asked the retailer where you purchased it whether your product is affected by this recall, or contact Chattem as indicated below.

What steps should I take if my patches are affected by the recall?

If you have one of the recalled products, you should stop using it immediately, and discard or return it to Chattem, Inc. Product may be returned for a full refund (average retail price) by calling Chattem’s Consumer Affairs Department at 1-888-442-4464 or via their website at www.Chattem.com.

To read more about the recall:

• FDA Recall Notice at http://www.fda.gov/oc/po/firmrecalls/chattem02_08.html

Consumers with questions may contact:

• Chattem’s Consumer Affairs Department at 1-888-442-4464 (M-F 8am to 4pm EST).

How do I report adverse events to FDA?

If you have experienced burns, skin irritation or other adverse reactions with the use of this product or any medical device, we encourage you to report this to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online:www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at:
  www.fda.gov/MedWatch/getforms.htm.
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178
  

tag: Icy Hot Heat Therapy Air Activated Heat recall, Icy Hot Heat Therapy recall, FDA Recall, Aspercreme, Chattem recall,

FDA's Recent Generic Drug Approvals

Each year, FDA approves scores of generic drugs that treat a variety of conditions and help consumers save money.

Generic drugs cost about 20% to 70% less than their brand name counterparts. The Congressional Budget Office has reported that generic drugs save consumers an estimated $8 billion to $10 billion a year.

Generic drugs are identical to their brand-name equivalents in dosage, safety, strength, quality, performance characteristics, intended use, and the way they're administered to patients.

Significant approvals granted by FDA's Office of Generic Drugs during the past year include

• Alendronate Sodium Tablets
  Used for: Treating and preventing types of osteoporosis
  Originally marketed as: Fosamax, by Merck & Co.
  Date approved: Feb. 6, 2008
• Carvedilol Tablets
  Used for: Treating hypertension and heart failure
  Originally marketed as: Coreg, by SmithKline Beecham, now GlaxoSmithKline
  Date approved: Sept. 5, 2007
• Cetirizine HCl Tablets
  Used for: Treating symptoms of allergies
  Originally marketed as: Zyrtec, by Pfizer
  Date approved: Dec.12, 2007
• Granisetron Tablets
  Used for: Preventing nausea and vomiting related to chemotherapy and radiation
  Originally marketed as: Kytril, by Roche
  Date approved: Dec. 31, 2007
• Oxcarbazepine Tablets
  Used for: Treating certain kinds of seizures and epilepsy
  Originally marketed as: Trileptal, by Novartis
  Date approved: Oct. 9, 2007
• Pravastatin Sodium Tablets
  Used for: Treating elevated cholesterol and preventing coronary events.
  Originally marketed as: Pravachol, by Bristol-Myers Squibb
  Date approved: Apr. 23, 2007
• Zolpidem Tartrate Tablets
  Used for: Treating insomnia
  Originally marketed as: Ambien, by Sanofi Aventis
  Date approved: Apr. 23, 2007

Drug manufacturers develop their new drugs under patents that protect their firms' investment in the products. When patents or other periods of exclusivity on the drugs expire, manufacturers can apply to FDA to sell generic versions.

In October 2007, FDA launched the Generic Initiative for Value and Efficiency (GIVE) to help increase the number of approvals of generic products.

GIVE will use existing resources to help FDA modernize and streamline the generic drug approval process. GIVE will also increase the variety of generic drug products available.

For More Information

FDA's GIVE Initiative
http://www.fda.gov/oc/initiatives/advance/generics.html

FDA's Office of Generic Drugs
http://www.fda.gov/cder/ogd/

Generic Drug Approvals (by month)
http://www.fda.gov/cder/ogd/approvals/default.htm

Date Posted: March 3, 2008

tag: FDA Approval, Drug Approvals, Alendronate Sodium Tablets, osteoporosis, Fosamax, Carvedilol Tablets, hypertension, Cetirizine HCl Tablets, Zyrtec, Granisetron Tablets, Kytril, Oxcarbazepine Tablets, Trileptal, Pravastatin Sodium Tablets, Pravachol, Zolpidem Tartrate Tablets, Ambien,

Tamiflu (oseltamivir phosphate) Advise For Patients With Influenza.

Tamiflu (oseltamivir phosphate)

Audience: Pediatric and infectious disease healthcare professionals
[Posted 03/04/2008] Roche and FDA informed healthcare professionals of neuropsychiatric events associated with the use of Tamiflu, in patients with influenza. These symptoms, as described in post marketing reports mostly from Japan, include delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated.

[February, 2008 - Dear Healthcare Professional Letter - Roche]
[January, 2008 - Tamiflu Prescribing Information - Roche]

tag: FDA Advisory, Tamiflu, neuropsychiatric events, influenza

Research On Alzheimer's and Parkinson's Gains Highly Promising Results.

LEIDEN, The Netherlands, -- Top Institute Pharma presents a new and highly promising research project. The TI Pharma project is a large-scale study into the brain material of Alzheimer's and Parkinson's patients, who gave permission to the Netherlands Brain Bank for their tissue to be used for scientific research. The analysis is a continuation of highly-promising results from previous studies and focuses on the genes that could be involved in the development of Alzheimer's disease and Parkinson's disease. The study - that must form the basis for potential drugs - is one of the largest to be carried out on an international level.

The project is being realized in cooperation with Solvay Pharmaceuticals B.V., DNage B.V., the Netherlands Institute for Neuroscience, the Netherlands Brain Bank, VU University Amsterdam, VU Medical Center, the Leiden University Medical Center, Utrecht University, University Medical Center Utrecht and the Erasmus MC in Rotterdam.

It is a follow-up to previous studies carried out by two public-private partnerships: that between Solvay Pharmaceuticals, the Netherlands Brain Bank and the Netherlands Institute for Neuroscience on the one hand, and DNage and the Erasmus Medical Center on the other. The highly promising results from both studies were the reason why TI Pharma opted for a large-scale project.

Principle investigator Joost Verhaagen of the Netherlands Institute for Neuroscience: "This study is unique in several aspects. Never before has such a large-scale study been carried out into Alzheimer's disease and Parkinson's disease. Moreover, we have been able to do research on people who did not yet know they had Alzheimer's disease or in whom the disease was only just starting. We can therefore follow the very first changes due to the disease as well as its progression. And that is also unique."

Additionally, this study is using rapidly-aging mouse models from DNage, in which Alzheimer and Parkinson like symptoms spontaneously occur. Following this neurodegeneration is also an interesting part of the study. Verhaagen: "We expect that this study will also yield new insights into the development of Alzheimer's disease and Parkinson's disease and that it could therefore form the basis for potential drugs."

Daan Crommelin and Victor Nickolson, scientific director and general director of TI Pharma respectively, are pleased that the top institute has this project under its wings. "TI Pharma has successfully consolidated the available strengths: companies, knowledge institutes and universities are now working together. Thanks to this partnership research results will be obtained far more quickly. And important steps can be made towards new drugs."

Alzheimer's disease is the most prevalent variant of dementia. Two-thirds of all patients who are demented suffer from Alzheimer's disease. The disease is characterized by a progressive deterioration of the psychological functioning. Alzheimer's disease usually starts at somewhere between 70 and 80 years of age, but can also start at a much younger age. It is estimated that some 24 million people worldwide suffer from Alzheimer's disease. There are 250,000 Alzheimer's patients in the Netherlands. Over the next few decades this number will double as a result of the aging population.

Parkinson's disease mostly begins at an older age of between 50 and 60 years. However, about 10% of the patients are younger than 40 years. Parkinson's disease is mainly characterized by a progressive disruption of the locomotor system that gravely affects the daily lives of patients and can be debilitating. The disease arises as a result of nervous cells in the midbrain dying. The cause of the disease is (still) not known and therefore prevention and cure are not possible.

tag: Alzheimer's, Parkinson's, Medical Research, Solvay Pharmaceuticals, DNage, Netherlands Institute for Neuroscience, Netherlands Brain Bank, VU University Amsterdam, VU Medical Center, TI Pharma project, the Leiden University Medical Center, Utrecht University,

Merck's Vioxx Settlement Is A Go.

Merck & Co. announced that enough people have signed on to pending $4.85 billion Vioxx settlement to keep the deal alive. More than 44,000 of the 47,000 claimants who registered injuries eligible for compensation have submitted some or all of the documentation required to seek a share of the settlement.

Vioxx was pulled from the market in 2004 when the widely used painkiller was linked to heart attacks and strokes. After a few years of fighting individual cases, a comprehensive settlement was proposed in last November.

WHITEHOUSE STATION, N.J., March 3, 2008 - Merck & Co., Inc. today said that more than 44,000 of the approximately 47,000 individuals who registered eligible injuries have submitted some or all of the materials required for enrollment that could qualify them for an interim payment in the program to resolve state and federal myocardial infarction (MI) and ischemic stroke (IS) claims filed against the Company in the United States. If all of these eligible submissions are completed in accordance with the Settlement Agreement, this would represent more than 93 percent of the eligible MI and IS claims previously registered with the program. In addition, approximately 5,000 other claimants have also sought to enroll and their eligibility status still has to be determined.

As of Feb. 29, the Claims Administrator reports more than 27,750 eligible MI claimants have initiated enrollment, more than 16,000 eligible IS claimants have initiated enrollment, more than 5,500 eligible MI and IS claimants alleging death as an injury have initiated enrollment, and more than 26,500 eligible MI and IS claimants alleging more than 12 months of use have initiated enrollment. Each of these numbers appears to represent at least 93 percent of the eligible claims in each category. These numbers do not include the additional 5,000 enrollees whose eligibility has yet to be determined.

"We are very pleased with the large number of enrollments we are seeing and are confident that when the enrollments are verified, all 85 percent thresholds will be met and exceeded within the timeframes in the agreement," said Ted Mayer, of Hughes Hubbard & Reed, one of Merck's coordinating defense counsel. "We are now working with the Claims Administrator to examine the registration and enrollment materials that have been received and continue to come in. There is a considerable amount of documentation that has to be reviewed before the definitive determination can be made that the thresholds have been met."

The timely meeting of the thresholds with enrollment documents in compliance with the Settlement Agreement would obligate Merck to pay $4.85 billion in installments into the resolution fund.

The thresholds are: (a) 85 percent or more of all eligible MI claims; (b) 85 percent or more of all eligible IS claims; (c) 85 percent or more of all eligible claims claiming death as an injury; and (d) 85 percent or more of all eligible claims alleging more than 12 months of use.

Claimants Eligible for Interim Payments
Under the Nov. 9, 2007 agreement, U.S. claimants who enroll in the resolution program by Feb. 29, are eligible to receive an interim payment, provided the claim ultimately qualifies for payment.

In recent weeks, several plaintiffs' firms reported that a substantial number of claimants who wanted to enroll needed additional time to submit complete enrollment packages. As a result, the Company and the plaintiffs' firms decided that claimants who have submitted initial submissions by Feb. 29 will receive a 31-day grace period, ending March 31, to complete their enrollment submissions with additional documentation, including properly executed releases and medical record authorization forms.

Provided the submissions are completed and verified, and participation thresholds are reached in a timely manner, those claimants will be eligible for interim payments, starting as early as August.

No Causation
Under the settlement agreement, Merck does not admit causation or fault with respect to these claims.

Merck Confirms that Eligible Claimants Can Still Enroll in Resolution Program
Eligible claimants who do not qualify for interim payments may still enroll in the resolution program if the claims were filed or tolled prior to Nov. 9, 2007 and their claims will be counted toward the participation thresholds as provided by the agreements. If participation thresholds are met in a timely manner, claimants will be able to enroll in the program through Oct. 30.

Criteria Under the Agreement
The resolution program is open only to U.S. legal residents and claimants whose alleged injury occurred in the United States.

To qualify for a payment, claimants also must satisfy three eligibility gates: 1) an injury gate requiring objective, medical proof of MI or IS (as defined in the agreement); 2) a duration gate based on documented receipt of at least 30 VIOXX pills; and 3) a proximity gate requiring receipt of pills in sufficient number and proximity to the event to support a presumption of ingestion of VIOXX within 14 days before the claimed injury.

Claimants who satisfy the eligibility gates will have their claims further evaluated by the Claims Administrator, who will make an objective evaluation of documented medical injuries and specific risk factors. This evaluation will be the basis for determining the amount to be paid to each claimant.

The Company recorded a fourth-quarter 2007 pre-tax charge in the amount of $4.85 billion to cover the cost of the agreement.

The Company will continue to defend all claims that are not included in the resolution program.

Status of Litigation
Juries had decided in favor of the Company 12 times and in plaintiffs' favor five times. One Merck verdict was set aside by the court and has not been retried. Another Merck verdict was set aside and retried, leading to one of the five plaintiff verdicts. There have been two unresolved mistrials.

As of Dec. 31, 2007, in the United States, the Company had been served or was aware that it had been named as a defendant in approximately 26,500 lawsuits, which include approximately 47,275 plaintiff groups alleging personal injuries resulting from the use of VIOXX, and in approximately 262 putative class actions alleging personal injuries and/or economic loss.

tag: Drug Litigation, vioxx, Vioxx Settlement, Merck,

New General Counsel For CPSC, U.S. Consumer Product Safety Commission

WASHINGTON, D.C. – The Acting Chairman of the U.S. Consumer Product Safety Commission today announced the hiring of Cheryl Falvey as the agency’s new career General Counsel effective March 3, 2008.

"Ms. Falvey is highly experienced in product safety issues," said Nord. “Her expertise will greatly benefit CPSC as it continues its work to reduce deaths and injuries associated with consumer products."

Falvey will assume her new position as a career member of the Federal Senior Executive Service (SES). The position of CPSC General Counsel had previously been a “political” (Schedule C) position, but was upgraded and changed at the initiative of the Commission.

“Making the General Counsel a career SES position will enhance the credibility and long term stability and professionalism of this very important position at the CPSC,” said Nord.

Prior to her appointment as CPSC’s new General Counsel, Falvey was a partner at the law firm Akin Gump Strauss Hauer & Feld LLP, in the Washington, DC office. She headed the firm’s litigation practice group in Washington, and advised clients on consumer product safety issues and product recalls, with a special focus on toys, children’s products, and household electronics and appliances. Falvey joined Akin Gump in 1990 after several years of practice with a New York law firm.

“I am extremely pleased to join the U.S. Consumer Product Safety Commission,” said Falvey. “I look forward to working with the CPSC’s talented staff to assist them with their mission to protect children and families against consumer product hazards.”

Falvey received her B.A. from Wellesley College in 1984. She received her J.D. from the Georgetown University Law Center in 1987 and served as editor of the American Criminal Law Review while at Georgetown. She is a member of the Virginia, New York, and District of Columbia Bars.

tag: CPSC, General Counsel CPSC

Talking Parents (About Sex), Leads To Healthy Teens!

Recent study conducted by a group of scientists and supported by National Institute of Mental Health and Centers for Disease Control, suggests that speaking to children regularly about sex may keep them from involving in risky sexual behaviors.
The study
included 312 teens and their parents. All participants were given baseline questionnaire and the teens were assured that their parents would not see their answers. The parents were then divided into two groups. Half of the parents were sent home without giving any further instructions. The other half attended an eight-week worksite-based parenting intervention class called "Talking Parents, Healthy Teens," designed to ease parent teen communication in difficult subject matters like sex.

There were Follow-up surveys conducted at intervals of one week, three months and nine months. The surveys assessed 22 sex-related topics, such as "how you will make decisions about whether to have sex,", "consequences of [getting pregnant/getting someone pregnant],""how to choose a method of birth control," "what it feels like to have sex," "how well condoms can prevent sexually transmitted diseases," and "how to say no if someone wants to have sex and you don't want to" and more.

At each follow-up survey, adolescents were presented with the same list of 22 topics and asked to report whether they had discussed each topic with their mother or father since the last survey. This helped researchers to assess how the parent teen communications were conducted.

They found that when teens and their parents had more conversations, often, teens reported feeling closer to their parents. This made them feel that they could talk more openly with their parents about sex or any other topic for that matter. A greater breadth of communication was associated with a perceived ease of discussing sex between parent and child, according to the study. But opening up and communicating closely with your children may also give you similar results. I had two good friends, infact they were my best friends, my parents. (I never got anyone pregnant, nor got infected with any sexually transmitted diseases. Basically I am a happy individual and I owe a lot to my parents for that.

Following is ths abstract of the study and the complete paper could be read at the pediatrics, a link to which is provided at the end of this article.