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