MEDDESKTOP: May 2008

Friday, May 30, 2008

QSWW - World No Tobacco Day Celebration.

I have not been able to keep up with weekly posting of my Stop Smoking series as I promised to you and the bloggers who run the Meddesktop. But I was busy with some other stuff from the life. But tomorrow being the "World No Tobacco Day" I thought it is time for me to pick up my gears and write.
I have made a lot of mistakes as a young man but I have never regretted those except my smoking. I went on to earn a PHD in Physics and yet could not understand the damage I was doing to myself with smoking.
I was too Dependant on smoking needlessly to the extent that I was scared to give up smoking, even to try. I imagined all sort of things and listened to stories about people falling apart trying to give up smoking.
All those were proven wrong when I tried to give up smoking for the first time. It was a like sailing through mildly choppy waters. (I am taking sailing lessons now).
You can get where you want but need to keep your sails, wing and rudder in check. But it is no big deal. After smoking for more than 25 years, I just gave up over a long weekend. Yes I started on a Friday (Thursday evening) and I was working on Monday.
I had to go through cravings, going crazy without the security blanket that you had all those years. I would walk in to the balcony (I never smoked inside the house, except in the bathroom that had a giant vent) only to realize that I don't smoke any more. I did not have to go downstairs at work every hour no more. All those were fine but the pride that I was able to escape the grips of cigarettes and be a non smoker is the greatest feeling. The only regret I have is for not trying earlier.
All you need is to think, "Yes I Can and I Want To Stop Smoking" It will work. Now to a little bit about "No Tobacco Day".

The tobacco industry catches all of us very young. How do they do that? well you can learn more about tobacco industry's advertising, promotion and sponsorship tactics and how they are a threat to you and everyone near and far from you, please visit this site.
WHO, World Health Organization site for more information so that you can help yourself and others..

Continuation of Series Articles;
1. Quit Smoking and Weight Watching Article Series.
2. QSWW Prelude! Quit Smoking and Weight Watching Article Series.
3.QSWW-S1, Quit Smoking and Weight Watching - Supplemental 1.
4.QSWW - World No Tobacco Day Celebration.

Hurricane Season Begins & Be Aware Of CO, Carbon Monoxide Poisoning.

Click on the image to download the PDF file, Print It and Give.

WASHINGTON, D.C. - June 1st marks the start of hurricane season. As you put your hurricane plan in place to protect your family and your home, CPSC is urging consumers to include a plan for after the storm.

If a storm knocks out power, consumers who use portable gasoline generators to restore power can place themselves at risk for carbon monoxide (CO) poisoning. Only use portable generators outdoors, far away from the doors, windows and vents of indoor spaces. Generators should never be used indoors, including inside homes, garages, basements, crawlspaces and sheds.

The amount of CO from one generator is equivalent to hundreds of idling cars in a garage and can kill consumers in minutes. At least 65 people died from CO poisoning associated with portable generators in 2006.

CPSC also advises consumers to keep charcoal grills outside. Never use them indoors. Burning charcoal in an enclosed space can produce lethal levels of CO.

If flooding occurs after a storm, do not use gas or electrical appliances or equipment that has been submerged. The electrical components and safety controls may be damaged and burner parts may be plugged with debris, leading to a fire risk. Have fireplaces, furnaces, and other heating equipment inspected by a professional to make sure they are working properly.

CPSC recommends that consumers install CO alarms in their homes as a line of defense against CO poisoning. Battery operated CO alarms or plug-in alarms with battery back-up add an important layer of protection in consumers’ homes. Remember to replace CO alarm batteries annually.

For more information on protecting your family against CO poisoning, visit www.cpsc.gov/CPSCPUB/PUBS/464.pdf and www.cpsc.gov/CPSCPUB/PUBS/468.html

Wednesday, May 28, 2008

Request for Comments: Potential for a Registry of Breast Cancer Treatment Using Thermal Ablation Devices.

SUMMARY: The Food and Drug Administration (FDA) is requesting comments on whether a registry could facilitate standardization of feasibility trials studying local treatment of small breast cancers with different thermal ablation devices and therapies (i.e. cryoablation, focused ultrasound, interstitial laser, microwave, radiofrequency ablation). FDA is specifically interested in understanding how breast cancer ablation feasibility trials can be constructed so that there exists standardized evaluation of tissue biopsy pathology, selection of tumors amenable to ablation, image guidance for ablation, post-ablation imaging and assessment, and tissue pathology of ablated specimens. The agency seeks to facilitate its understanding of local treatment for breast cancer using thermal ablation devices.

DATES: Submit written or electronic comments by November 24, 2008.

ADDRESSES: Submit written comments concerning this document to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.
To ensure timelier processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail.

FOR FURTHER INFORMATION CONTACT: Binita Ashar or Long Chen, Center for Devices and Radiological Health (HFZ-500), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-3600, e-mail: binita.ashar@fda.hhs.gov or long.chen@fda.hhs.gov.
The complete documents could be viewed either at FDA or ar Regulations.gov.

Tuesday, May 27, 2008

Fake ED Products Online Might Be Harmful To You.

Click on the image to download a PDF version of this document

After reading the previous recall I decided to republish this document by FDA regarding medicine to treat erectile dysfunction drugs called "Buying Fake ED Products Online". But these treatments brings serious medical conditions. Read the complete document and educate yourself. Download a PDF version of this document by clicking on the image above or here.

Men looking online for "dietary supplements" to treat erectile dysfunction (ED) or enhance their sexual performance should beware: these products may contain prescription drugs or other undisclosed ingredients that can be harmful.

"The number of these problematic products available on the Internet appears to be increasing," says Linda Silvers, leader of FDA's Internet and Health Fraud Team, part of the Office of Compliance (OOC) in the Center for Drug Evaluation and Research (CDER).

"Many consumers perceive these products as completely safe because they are often sold with labeling, suggesting that they are all-natural alternatives to prescription drug products that have been approved by FDA for treating ED," she says. "But these products may be laced with potentially hazardous ingredients that aren't noted on the label."
Since 2004, FDA has become aware of several such "dietary supplements" (see sidebar for list).

Viagra Ingredient Found

Working with other FDA components, Silvers' team led an Internet survey in which more than one-third of purchased "dietary supplements" claiming to spur sexual enhancement or treat ED contained undisclosed prescription drug ingredients or similar substances.

"Six of the 17 products we bought contained sildenafil (the active ingredient in Viagra) or a substance similar to either sildenafil or vardenafil," says Silvers. Vardenafil is the active ingredient in Levitra, another FDA-approved prescription drug that treats ED.

Mark Hirsch, a Medical Team Leader in CDER's Division of Reproductive and Urologic Products, says this undisclosed presence of prescription drug ingredients—and similar compounds known as analogs of the drugs—can lead to serious side effects in users.

Dangerous Interactions

"These products may interact in dangerous ways with drugs that a consumer is already taking," Hirsch says. For example, taking sildenafil in addition to certain prescription drugs containing nitrates may lower blood pressure to an unsafe level.

People with diabetes, high blood pressure, high cholesterol, or heart disease are often prescribed drugs containing nitrates, and men with these conditions commonly suffer from ED, Hirsch says. "Those are factors that doctors consider when prescribing approved ED treatments."

Preventive Measures

Silvers says FDA has determined that many of these products or their active ingredients are imported into the United States from other countries.

"FDA is working closely with U.S. Customs and Border Protection to develop a more effective network to successfully screen and stop these shipments from entering U.S. commerce," says Sally Eberhard, Acting Team Leader of OOC's Import-Export Team.

Silvers adds that the agency is also evaluating innovative ways to educate consumers about the risks of buying such sexual enhancement products and other drugs online.

horizontal rule

Online Products to Avoid

Since 2004, FDA has identified several products sold online as so-called "dietary supplements" for treating erectile dysfunction and enhancing sexual performance. These products have contained potentially harmful, undeclared ingredients. Included among them are

Actra-Rx
Actra-Sx
Libidus
Nasutra
Neophase
Vigor-25
Yilishen
Zimaxx
4EVERON
Liviro3
Lycium Barbarum L.
Adam Free
Rhino V Max
V.Max
True Man
Energy Max
HS Joy of Love
NaturalUp
Blue Steel
Erextra
Super Shangai
Strong Testis
Shangai Ultra
Shangai Ultra X
Lady Shangai
Shangai Regular, also marketed as Shangai Chaojimengnan
Hero

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For More Information

FDA Issues Health Risk Alert for 'True Man' and 'Energy Max' Products
www.fda.gov/bbs/topics/NEWS/2007/NEW01633.html

FDA Requests Recall of 'True Man Sexual Energy,' 'Energy Max' Dietary Supplements
www.fda.gov/bbs/topics/NEWS/2007/NEW01737.html

FDA Warns Consumers About Dangerous Ingredients in "Dietary Supplements" Promoted for Sexual Enhancement
www.fda.gov/bbs/topics/NEWS/2006/NEW01409.html

FDA Warns Consumers Not to Use "Blue Steel" and "Hero" Products
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01809.html

Recallr: FDA & The state of Florida Orders Recall Of ED Drug, Xiadafil VIP Tablets By SEI Pharmaceuticals.

Another unapproved ED Drug has been recalled. The FDA has not approved Xiadafil VIP Tabs for ED or any other drug use, and the safety and effectiveness of this product is unknown. The product is promoted and sold over the Internet, was given away as free samples at trade shows, and is sold in health food stores nationwide. The product may be packaged in bottles of eight tablets or blister cards of two tablets.
If you need these type of medication, please visit your doctor.
Recallr: FDA & The state of Florida Orders Recall Of ED Drug, Xiadafil VIP Tablets By SEI Pharmaceuticals.

Tags: FDA Recall, Drug Recall, Xiadafil VIP Tablet recall, SEI Pharmaceuticals recall, all-natural, Erectile Dysfunction Drug

Control Your Cholestrol With Statins.

Click on the image to download a printable PDF version of this document.

When it comes to keeping your heart healthy, what foods you eat and the genes you inherit matter. Good heart health also may depend on the drugs you take. Several medicines are effective at lowering blood cholesterol levels—a key factor in good heart health. Chief among them are the statins.

Statins (HMG-CoA reductase inhibitors) are one class of many drugs used to lower the level of cholesterol in the blood by reducing the production of cholesterol by the liver. Statins block the enzyme in the liver that is responsible for making cholesterol. Too much cholesterol can increase a person's chance of getting heart disease. According to the Centers for Disease Control and Prevention, heart disease is the leading cause of death for both women and men in the United States.

Understanding Cholesterol

Cholesterol is a waxy substance found in all parts of the body. It is critical to the normal function of all cells. The body needs cholesterol for making hormones, digesting dietary fats, building cell walls, and other important processes. Your body makes all the cholesterol it needs, but cholesterol is also in some of the foods you eat.

When there is too much cholesterol in your blood, it can build up on the walls of the arteries (blood vessels that carry blood from the heart to other parts of the body). This buildup is called plaque. Over time, plaques can cause narrowing or hardening of the arteries—a condition called atherosclerosis. In short, too much cholesterol can clog your arteries and keep your heart from getting the blood it needs.

Cholesterol Numbers That Matter

There are no warning symptoms of high cholesterol. But a simple blood test by your doctor will measure the different kinds of cholesterol.

Low-density lipoprotein (LDL) or "bad" cholesterol can clog the arteries. Lower numbers of LDL are best. The higher the LDL level, the greater the risk for heart disease.

High-density lipoprotein (HDL) or "good" cholesterol carries bad cholesterol out of your blood, back to the liver, where it can be eliminated, to keep it from building up in the arteries. The higher the HDL level, the lower the risk for heart disease.

For information on what your cholesterol numbers mean, visit FDA. (We will also have an article about it soone.)

What Affects Cholesterol?

The following factors affect blood cholesterol levels:

* Certain foods - eating too much saturated fat, found mostly in animal products, and too much cholesterol, found only in animal products
* Heredity - genes play a role in influencing the levels
* Weight - excess weight tends to increase the levels
* Exercise - regular physical activity may not only lower LDL cholesterol, but it may increase the level of desirable HDL cholesterol
* Smoking - cigarette smoking lowers HDL cholesterol
* Age and gender - cholesterol levels naturally rise as men and women age. Menopause is often associated with increased LDL cholesterol in women.

State of the Statins

The main goal of cholesterol treatment is to lower LDL to levels that will not lead to or worsen heart disease. When a patient without heart disease is first diagnosed with elevated blood cholesterol, the National Cholesterol Education Program guidelines advise a six-month program of reduced dietary saturated fat and cholesterol, together with physical activity and weight control, as the primary treatment to bring levels down.

When diet and exercise alone are not enough to reduce cholesterol to goal levels, doctors often prescribe medication—the most prominent being the statins. By interfering with the production of cholesterol, statin medications can slow the formation of plaques in the arteries.

Statins are relatively safe for most people, but some can respond differently to the drugs. Certain people may have fewer side effects with one statin drug than another. Some statins, in particular Lovastatin and Simvastatin, also are known to interact adversely with other drugs. This information, coupled with the degree of cholesterol-lowering desired, will help guide the decision about which statin to use, or whether another type of drug should be used.

Statin medications (HMG-CoA reductase inhibitors)

* work in the liver to prevent formation of cholesterol
* are effective in lowering bad cholesterol levels and raising good cholesterol
* are not recommended for pregnant patients or those with active or chronic liver disease
* can cause serious muscle problems

Currently available statins

* Lovastatin (Mevacor, Altoprev)
* Pravastatin (Pravachol)
* Simvastatin (Zocor)
* Fluvastatin (Lescol)
* Atorvastatin (Lipitor)
* Rosuvastatin (Crestor)

Tips for Consumers

* Have your blood cholesterol levels checked at least once every 5 years if you are an adult 20 years or older.
* Check with your doctor. You may be able to lower your cholesterol levels by eating better and exercising more.
* Maintain a healthy weight. Being overweight increases your risk for heart disease.
* Stay active every day.
* Use the food label to choose foods lower in saturated fat, including trans fats, and calories.
* Eat more fruits and vegetables.
* Don't stop taking any cholesterol-lowering medications you may be on without first talking to your doctor.

For More Information

National Heart, Lung, and Blood Institute Health Information Center

FDA's Center for Drug Evaluation and Research

Mommy's Bliss Nipple Cream Can Be Harmful To Nursing Infants

FOR IMMEDIATE RELEASE
May 23, 2008

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

FDA Warns Consumers Against Using Mommy's Bliss Nipple Cream
Product can be harmful to nursing infants

The U.S. Food and Drug Administration is warning consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. The product is promoted to nursing mothers to help soothe and heal dry or cracked nipples. Product labeling specifically states that there is no need for mothers to remove the cream prior to nursing. However, the ingredients contained in the product may be harmful to nursing infants.

Potentially harmful ingredients in Mommy's Bliss Nipple Cream are chlorphenesin and phenoxyethanol. Chlorphenesin relaxes skeletal muscle and can depress the central nervous system and cause respiratory depression (slow or shallow breathing) in infants. Phenoxyethanol is a preservative that is primarily used in cosmetics and medications. It also can depress the central nervous system and may cause vomiting and diarrhea, which can lead to dehydration in infants.

Mothers and caregivers should watch for a decrease in an infant's appetite. More serious signs would be difficulty in awakening the child, limpness of extremities or a decrease in an infant's strength of grip and a change in skin color. Please seek immediate medical attention if your child is showing these signs and symptoms.

"The FDA is particularly concerned that nursing infants are being unwittingly exposed by their mothers to this product with dangerous side effects," said Janet Woodcock, M.D., director, FDA's Center for Drug Evaluation and Research. "Additionally, these two ingredients may interact with one another to further compound and increase the risk of respiratory depression in nursing infants."

Though the FDA has not received any reports of injury to infants, the agency is alerting the public because of the potential harm this product can have on a child.

Chlorphenesin can also harm the mother by causing dermatitis, a skin condition that can worsen the drying and cracking of nipple skin.

MOM Enterprises, Inc. is based in San Rafael, Calif. The company has stated that it has discontinued marketing the nipple cream with the potentially harmful ingredients. The FDA is advising consumers to discontinue use of Mommy's Bliss Nipple Cream and to consult a health care professional if they experience problems or believe that their infant may have experienced problems due to this product. Nursing mothers with cracked, painful nipples, which is often a side effect of nursing, should speak with their health care professional or a certified lactation consultant if the problem is severe or for other treatment options.

Consumers are strongly encouraged to report adverse events related to this product or any FDA approved product to MedWatch, the agency's voluntary reporting program, by e-mail at www.fda.gov/medwatch/report.htm, or by phone at 800-332-1088, or by fax to 800-332-0178. Consumers may also mail reports of adverse events to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.

Friday, May 23, 2008

Recallr: Health Canada is warning consumers not to use "Desire", labelled as manufactured by Desire LLC, and distributed by StarChem Labs.

Desire is labelled as manufactured by Desire LLC, and distributed by StarChem Labs, of Farmingdale, New York. The product may be available at retail outlets across Canada, and over the Internet.

Health Canada advises retailers to remove Desire from their shelves, and consumers should return the product to the place of purchase. Health Canada is taking steps to confirm that the product has been removed from the Canadian market. Health Canada has not received any reports of adverse reactions associated with this product. Canadians who have used Desire LLC and are concerned about their health should consult with a health care professional.

Health Canada advises consumers not to use Desire or any other unauthorized products promoted to increase sexual performance that are advertised as "all natural", as such products may contain undeclared prescription drugs that may pose serious risks to health. Consumers who are concerned about erectile dysfunction should consult with their health care professional to discuss appropriate and authorized treatments.

Drugs and natural health products that are authorized for sale in Canada have an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Drug Identification Number for Homeopathic Medicine (DIN-HM) on the label.

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.

Recallr: Health Canada is warning consumers not to use "Desire", labelled as manufactured by Desire LLC, and distributed by StarChem Labs.
Health Canada, Health Canada advisory, Desire LLC, StarChem Labs, phentolamine, heart problems, Canada Vigilance Program, male sexual performance enhancement

USDA To Ban Downer Cows From Slaughter Houses.

Secretary of Agriculture has announced plans to remove the loophole that slaughter houses were using to slaughter downer cows, non ambulatory or injured cows, and introduce those meat in to the food chain. The recently discovered violations by Hallmark/Westland Meat Packing Company in Chino, California that prompted largest beef recall in the history. According to the following statement, secretary has instructed FSIS to draft a proposed rule to remove the exception that allows certain injured cattle to proceed to slaughter. This action is expected to provide additional efficiencies to food safety inspection by removing the step that requires inspection workforce to determine when non-ambulatory cattle are safe to slaughter.
We all have to thank humane society of America for discovering and reporting the perpetrators.

AGRICULTURE SECRETARY ED SCHAFER ANNOUNCES PLAN TO END EXCEPTIONS TO ANIMAL HANDLING RULE

WASHINGTON, May 20, 2008- One day after I was sworn in as Secretary of Agriculture, I learned of the illegal acts of inhumane handling that took place at the Hallmark/Westland Meat Packing Company in Chino, California. I immediately called upon the Office of the Inspector General and the Food Safety and Inspection Service to determine how this happened and what could be done in the future to ensure that animals are treated humanely.

I told the American people and the United States Congress that I was going to treat this issue with the utmost urgency, and do everything in my power to appropriately address this problem and work to strengthen consumer confidence in our food supply. We found clear evidence that rules weren't being followed which resulted in USDA calling for the largest beef recall in American history – a clear sign that we took these inhumane violations seriously. Rules have purpose, and when you violate them, there are consequences.

I felt it was important to take proactive steps to assess the state of humane handling activities in cattle slaughter establishments while the OIG and FSIS investigations are ongoing, and on February 28, I instructed FSIS to initiate a number of interim action items related to inhumane handling.

The 60-day enhanced surveillance period concluded on May 6 and while we are still analyzing those results, today I am announcing that USDA will begin working on a proposed rule to prohibit the slaughter of all disabled non-ambulatory cattle, also know as "downer cattle." In other words, I am calling for the end of the exceptions in the so called "downer rule."

Last year, of the nearly 34 million cattle that were slaughtered, under 1,000 cattle that were re-inspected were actually approved by the veterinarian for slaughter. This represents less than 0.003 percent of cattle slaughtered annually. As you can see, this number is minimal.

The current rule, which focuses on cattle that went down after they have already passed pre-slaughter inspection, has been challenging to communicate and has, at times, been confusing to consumers.

To maintain consumer confidence in the food supply, eliminate further misunderstanding of the rule and, ultimately, to make a positive impact on the humane handling of cattle, I believe it is sound policy to simplify this matter by initiating a complete ban on the slaughter of downer cattle that go down after initial inspection.

FSIS will draft a proposed rule to remove the exception that allows certain injured cattle to proceed to slaughter. This action is expected to provide additional efficiencies to food safety inspection by removing the step that requires inspection workforce to determine when non-ambulatory cattle are safe to slaughter.

The decision to ban all non-ambulatory cattle from slaughter will positively impact the humane handling of cattle by reducing the incentive to send marginally weakened cattle to market.

Cattle producers, transporters and slaughter establishments alike will be encouraged to enhance humane handling practices, as there will no longer be any market for cattle that are too weak to rise or walk on their own.

In February, I said that we would look into every option, and more importantly, we would listen and base our decisions on sound policy. I believe this announcement today strikes the right balance, and will benefit our efforts to not only improve consumer confidence, but improve the humane handling of animals.

Thursday, May 22, 2008

FDA And CMS Joins To Improve Quality of Medical Care And Patient Safety.

HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care.

“This initiative will tremendously increase the FDA’s capacity to monitor the use of medical products on the market,” Secretary Leavitt said. “We are moving from reactive dependence on voluntary reporting of safety concerns -- to proactive surveillance of medical products on the market. In addition, Medicare data on prescription drug use will be available to help government agencies and academic researchers improve the safety, quality and efficiency of health care services.”

In a white paper released by the FDA today, the agency describes plans for the Sentinel Initiative, which will include the development of a new electronic system that will enable FDA to query a broad array of information to identify possible post-market adverse events. That Sentinel System will be created through public-private partnerships and will capitalize on existing large electronic claims and medical records data sources maintained by private and government entities that agree to participate in this nationwide effort.

A CMS final regulation published today will make it possible for federal agencies, states, and academic researchers to use claims data from the Medicare prescription drug program (Part D) -- subject to protections for beneficiary privacy and commercially sensitive data -- for public health and safety research, quality initiatives, care coordination and other research and analysis.

The Sentinel System is an important example of how electronic health records and other electronic health information, such as the Medicare data, can help move the nation toward a system that delivers safer and better quality health care. President Bush has set the goal of most Americans having access to an interoperable electronic health record by 2014.

Continue reading here.

Wednesday, May 21, 2008

Entereg By Adolor Corporation, Approved By FDA To Help Restore Bowel Function Following Surgery

FOR IMMEDIATE RELEASE
May 20, 2008

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

FDA Approves Entereg to Help Restore Bowel Function Following Surgery

The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses.

"Patients who have undergone abdominal surgery and are on pain medications often experience problems eliminating waste," said Joyce Korvick, M.D., deputy director, Division of Gastroenterology Products. "Entereg will help accelerate their recovery, improve bowel function, and get these patients back on a normal diet. As with all FDA-approved products, the agency will monitor Entereg throughout its life cycle."

FDA is approving Entereg with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh the risks. The REMS will include limits on dispensing of the drug.

In approving Entereg, FDA determined that a REMS is necessary to ensure that the benefits of Entereg outweigh its risks. The REMS will include restricting Entereg to inpatient use only, requiring that hospitals be specially certified, distribution of educational materials to health care professionals, and regular assessments of the effectiveness of the REMS.

Following major abdominal surgery, some patients develop a condition known as postoperative ileus (POI). POI is a disorder that causes temporary impairment of the gastrointestinal (GI) tract's motility, or the ability of the intestines to push out waste products (not a complete blockage of the GI tract), following surgery. POI can be a by-product of a patient taking opioid pain relievers, like morphine, prescribed after surgery which can slow or inhibit normal motility. Entereg works by blocking opioid effects in the bowel.

The recommended dose for Entereg is one 12 milligram (mg) capsule given just prior to surgery and then another 12 mg dose administered twice daily for up to 7 days or not to exceed 15 doses. The product will only be available to hospitals and will come in blister packs that are marked "HOSPITAL USE ONLY." Entereg is not approved for use in pediatric populations.

The safety and efficacy of Entereg in post-operative patients were demonstrated in five studies that included 2,177 patients, of whom 1,096 received Entereg and 1,081 received placebo. Bowel recovery times ranged from 10 to 26 hours shorter for Entereg-treated patients compared to placebo-treated patients in the five studies. The most common side effects reported were low blood calcium levels, anemia and gastrointestinal problems, including constipation, dyspepsia (heartburn) and flatulence (excess bowel gas).

FDA has reviewed a 12-month study of Entereg in patients treated with opioid medications for chronic pain. In this study, there were more reports of myocardial infarctions in patients treated with a 0.5 mg dose of Entereg twice daily, compared with placebo-treated patients. This imbalance has not been observed in other studies of Entereg, including studies in patients undergoing bowel resection surgery who took 12 mg of Entereg, twice daily for up to seven days. A causal relationship with Entereg and myocardial infarction has not been established.

Consumers and health care professionals are encouraged to report adverse events to FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.

Adolor Corporation, the manufacturer of Entereg, is based in Exton, PA. Adolor and GlaxoSmithKline, London, England, are collaborating on the development and marketing of Entereg.

Tuesday, May 20, 2008

Do you have a killr Crib, Car seat, Stroller, Portable Crib?

56% of all infant carriers, 44% of all car seats, 40% of all strollers and 19% of all portable cribs were found to have high levels of halogenated fire retardants.
"We sampled a wide variety of children's products, and what we found was alarming," said Friends of the Earth's Sara Schedler, the report's lead author. "Toxic chemicals are being put into products that children and babies interact with on a regular basis, endangering their health. The government must act now to limit these chemicals’ use, and companies should stop putting these chemicals in their products."

May 20, 2008

For Immediate Release:

For more information contact:
Russell Long, Friends of the Earth, 415-302-4824
Sara Schedler, Friends of the Earth, 510-384-4954
Shannan Velayas, Assemblyman Leno’s office, 916-271-2867

'Killer Cribs' study by Friends of the Earth finds babies and infants are at risk; group asks manufacturer Graco to halt use of toxic chemicals; Legislation advancing in California

SAN FRANCISCO—Toxic fire retardant chemicals linked to cancer, birth defects, and neurological and other health problems are prevalent in common baby products, according to a study released today by national environmental group Friends of the Earth.

The study, “Killer Cribs: Protecting Infants and Children from Toxic Exposure,” is part of a story that aired last night on the CBS Evening News. The study finds that these toxic chemicals, called halogenated fire retardants, appear in a high percentage of baby products, including portable cribs, strollers, car seats and infant carriers. Due to their prevalence in common household products, these chemicals have been found in breast milk and in children. Infants and children are especially vulnerable to the health effects of these chemicals as they impact development at critical stages of growth.

“We’re poisoning our children, one crib at a time,” said Russell Long, Vice-President of Friends of the Earth. “Given the clear links to learning disorders and reproductive problems, this is beyond foolish. Fortunately, there are fire-safe alternatives, but the chemical industry is fighting hard to keep its profits at the expense of our kids.”

Friends of the Earth’s Sara Schedler, the report’s lead author said, “We sampled a wide variety of children’s products, and what we found was alarming. Toxic chemicals are being put into products that children and babies interact with on a regular basis, endangering their health. The government must act now to limit these chemicals’ use, and companies should immediately phase them of their products.”

The largest state in the nation may soon enact safeguards. A bill sponsored by California Assemblyman Mark Leno (AB 706) would end the use of these dangerous chemicals in many products and has already passed the California Assembly. Action is pending on the California Senate floor.

“Kids shouldn’t have to sleep on or play with toxic products that could cause long-term damage to their health,” Leno said. “Our bill would help ensure they don’t. It creates smarter and improved fire-safety standards while protecting kids, workers, and others from toxic chemical exposure. Today’s study from Friends of the Earth underscores the urgent need for the Senate to pass this legislation.”

Friends of the Earth also announced today that it is working with organizations including MOMS: Making Our Milk Safe and MomsRising.org to encourage baby and children’s product manufacturers to end the use of toxic fire retardant chemicals in their products. The groups are approaching juvenile product company Graco first, encouraging hundreds of thousands of activists and consumers to contact Graco and request that it take the lead within its industry by dropping the use of these chemicals.

The findings in the "Killer Cribs” report released today are based on a sample of 150 baby products and 350 pieces of household furniture from California stores and residences. More information is available from Friends of the Earth at http://killercribs.org.

All is not bad news, but there are products without these chemicals. You can find a list here.

Do not to use Trophic Kelp & Glutamic Acid HCl, Health Canada

OTTAWA - Health Canada is warning consumers not to use the natural health product Trophic Kelp & Glutamic Acid HCl due to the health risk posed by exposure to high levels of iodine. Women who are pregnant or breastfeeding, and individuals with thyroid disease such as Graves' disease are particularly at risk.Excessive iodine exposure can result in an enlarged thyroid and may cause either hypothyroidism (underactive thyroid disease) or hyperthyroidism (overactive thyroid disease) in susceptible individuals. Symptoms of hypothyroidism include weight gain, joint or muscle pain, fatigue, weakness, depression, increased sensitivity to cold, and abnormal menstrual cycles. Over time, untreated hypothyroidism may lead to infertility and heart disease. Hyperthyroidism symptoms include sudden weight loss, rapid or irregular heartbeat, increased sensitivity to heat, sweating, nervousness or irritability. Stroke is one of the most serious complications of hyperthyroidism.

Unborn babies are very sensitive to high levels of iodine and may be born with an enlarged thyroid. Significant swelling of the thyroid could compress the baby's windpipe and interfere with breathing. As well, high levels of iodine in individuals with thyroid disease such as Graves' disease may reduce the effectiveness of antithyroid medications.

Health Canada cautions consumers, especially women who are pregnant or breastfeeding, individuals with thyroid disease such as Graves' disease or individuals with previous iodine deficiencies, to be aware that kelp products contain iodine, and advises them to consult their health care practitioners prior to taking these products.

Trophic Kelp & Glutamic Acid HCl provides an excess amount of iodine. Although not approved for sale in Canada, the product was available at retailers and pharmacies across Canada, and over the Internet. Trophic Canada Ltd. has initiated a recall of the product. Health Canada will monitor the effectiveness of this recall. Consumers are reminded that drugs and natural health products that are authorized for sale in Canada have an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Drug Identification Number for Homeopathic Medicine (DIN-HM) on the label.

Health Canada advises retailers to remove Trophic Kelp & Glutamic Acid HCl from their shelves, and consumers should return the product to the place of purchase. Consumers who have taken the product and have health concerns should consult with a health care professional.

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 this health product, 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

Health Canada warns consumers not to use Trophic Kelp & Glutamic Acid HCl due to health risk

Monday, May 19, 2008

Google Health Opens For Service

Google Health finally has been launched and if you have to ask what Google Health is? it is an extension to your heath record information. You can store your health information with Google Health and manage it as you want. It's completely free. All you need to get started is a Google account ( Google username and password). If you have that you are set to go.

You also might wonder if it is safe? Yes! Google believes that your health information belongs to you, and you should decide how much you share and whom you share it with. Google also promise not to sell your data, and that the data is stored securely and privately. You can check out their privacy policy to learn more.

Once you login at the Google Health site, using your free Google Account, you can create and save a Google Health profile. You can enter as little or as much information as you want—for example, conditions, medications, and allergies.

You may also click the Reference links to read about symptoms, causes, and treatments.

You can even create additional profiles for your kids, your parents, or anyone you care about. This way you will have your whole family's health information from easy to access place. You, your doctor, or emergency health technician will be able to access these records from any where, as long as there is an Internet connection.

We all have a health records with information that span a few years. It will be hard to type in all those records. So Google has made the task easier by allowing you to import your information directly from your health care provider, hospital or doctor. They have partnered with hospitals, labs, and pharmacies to allow you to import your records and prescription history from healthcare providers that treat you. Linking accounts with these partners is secure. Just identify yourself by signing in at the partner's site with the username and login that you have with your provider, and then confirm that you want to link accounts and transfer data to Google Health. All will be done!

With Google Health, you can see your health information in an entirely new light. It can help you track your medical history. Use your profile to view a summary of your medical history, or drill down to see the details close up. Having all your health information organized and centrally located will help keep your doctors up-to-date when you visit them. Just point them to your records or print them out before visiting them.

One more fine things that you get is that whenever you add new health data to your profile, Google Health will cross check for potential interactions between your drugs, allergies, and conditions. Review these helpful tips to see if there are any issues you should talk to your doctor about.

You also can refill prescriptions online, ask for a second opinion, or get personalized health information based on your profile. You can link to these services in the same way you link to other partners to import your medical records. Google assures that it has no financial relationship with any of these companies and you can decide whether to connect with a service and share your health information with it.

And finally, Search for existing or new doctors by specialty or location. You can review professional details about doctors or easily view their business locations in Google Maps. You can search for hospitals too. Add all your providers to your medical contacts list so this important information is always close at hand.

So if you are interested, you can sign up at Google Health.

New Chantix (Varennicline) Medication Guide and Label Approved By FDA

FDA approves new Medication Guide and Label for Varenicline (marketed as Chantix)
FDA ALERT [2/1/2008]: FDA is issuing this Alert to highlight important revisions to the WARNINGS and PRECAUTIONS sections of the full prescribing information for Chantix regarding serious neuropsychiatric symptoms. Serious neuropsychiatric symptoms have occurred in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy.

FDA first informed the public about the possibility of serious neuropsychiatric symptoms in the November 20, 2007 FDA Early Communication About an Ongoing Safety Review. At that time, information about serious neuropsychiatric symptoms in patients taking Chantix was added to the POST-MARKETING EXPERIENCE section of the prescribing information. As FDA’s review of the issue has progressed, it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms. As a result, FDA requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information to the WARNINGS and PRECAUTIONS sections of the Chantix prescribing information. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients.

[5/16/2008]: The issues described in this communication have been addressed in the product labeling and FDA has approved the Medication Guide. If either you, your family or caregiver notice agitation, depressed mood, or changes in behavior that are not typical for you, or if you have suicidal thoughts or actions, stop taking Chantix and call your doctor right away.

FDA Alert & Information on Mycophenolate Mofetil (marketed as CellCept) and

FDA ALERT [5/16/2008] - Inosine Monophosphate Dehydrogenase Inhibitors (IMPDH) Immunosuppressants

FDA is aware of reports of infants born with serious congenital anomalies, including microtia and cleft lip and palate, following exposure to mycophenolate mofetil (MMF) during pregnancy. MMF, the active drug substance in CellCept, is an ester of the active metabolite mycophenolic acid (MPA), the active drug substance in Myfortic. In most cases, the mothers were taking MMF following an organ transplant to prevent organ rejection. However, some mothers taking MMF were being treated for immune-mediated conditions such as systemic lupus erythematosus (SLE) and erythema multiforme. Treatment began before their pregnancies and continued into the first trimester or until the pregnancy was detected. MMF is approved in the U.S. for use in the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants and MPA is approved in the U.S. for use in the prophylaxis of organ rejection in patients receiving allogeneic renal transplants. In patients who are transplant recipients, these drugs are almost always used in combination with other immunosuppressant drugs.

MMF and MPA increase the risk of spontaneous abortion in the first trimester and can cause congenital malformations in the offspring of women who are treated during pregnancy. The labeling for both MMF and MPA was revised in November 2007 to change the Pregnancy Category to "D" (positive evidence of human fetal risk, but potential benefits may warrant use of the drug in pregnant women despite the potential risk) and to add these findings about the risk of early pregnancy loss and congenital malformations to the boxed warning.

FDA is continuing to work with the manufacturers of these drug products to develop and implement means to mitigate the risks of fetal exposure.

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 potential association between the use of CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid), medicines used to prevent organ rejection, and the development of progressive multifocal leukoencephalopathy (PML), a life-threatening disease.

PML is a rare disorder that affects the central nervous system. When it occurs, it is usually in patients with immune systems suppressed by disease or medicines. It happens when the polyomavirus, also known as the JC virus, is activated. The JC virus is found in most adults but does not usually cause symptoms. Scientists do not know exactly how the JC virus is activated. Once activated, the JC virus attacks the cells that make myelin, the protective coating around nerve cells. Signs and symptoms of PML can include localized neurologic signs and symptoms including vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs. Many patients who develop PML die. Patients who survive may have permanent disability due to irreversible nerve damage. More information on PML can be found at the National Institutes of Health website.

CellCept is approved to prevent heart, liver, and kidney transplant rejection and Myfortic is approved to prevent kidney transplant rejection. Mycophenolate mofetil, the drug ingredient in CellCept, is metabolized by the body to mycophenolic acid, the drug ingredient in Myfortic. Both CellCept and Myfortic are used with other drugs to suppress the immune system.

On November 8, 2007, Roche, the maker of CellCept, submitted an evaluation of its PML cases in patients who have received CellCept in addition to other immunosuppressive medicines. Roche also submitted recommendations to the FDA for including information about PML in the CellCept prescribing information. On March 14, 2008, Roche informed the FDA of the Dear Health Care Professional letter it issued in Europe on February 18, 2008.

Roche is aware of cases of PML in transplant recipients and patients with systemic lupus erythematosus (SLE), an autoimmune disorder that is sometimes treated with CellCept; however, CellCept and Myfortic are not approved for treating SLE or similar autoimmune disorders.

FDA is reviewing data, including postmarketing reports it has received of PML in patients who took CellCept, and the proposed revisions to the CellCept prescribing information. FDA has asked Novartis, the maker of Myfortic to revise the Myfortic prescribing information to include the same information about PML included in the CellCept prescribing information.

FDA anticipates it may take about 2 months to complete its review of the postmarketing reports and the proposed revised prescribing information for CellCept and Myfortic about PML. As soon as FDA completes the review, FDA will communicate the conclusions and recommendations to the public. Until further information is available, patients and healthcare professionals should be aware of the possibility of PML, such as localized neurologic signs and symptoms in the setting of a suppressed immune system, including during therapy with CellCept and Myfortic. Decreasing total immunosuppression may improve the outcome of patients who develop PML.

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

FDA urges both healthcare professionals and patients to report side effects from the use of CellCept and Myfortic to the FDA's MedWatch Adverse Event Reporting program

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; or
by phone at 1-800-332-1088

Recallr: Medicis Recalls Solodyn® (minocycline HCL, USP) 90 Mg Tablets

Medicis today announced that the Company is voluntarily recalling lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of the antibiotic SOLODYN® (minocycline HCl, USP) Extended Release Tablets, 90 mg, 30-count bottles (NDC 99207-461-30).
Recallr: Medicis Recalls Solodyn® (minocycline HCL, USP) 90 Mg Tablets
FDA Recall, Drug Recall, Medicis Recalls, Solodyn Recall, AAIPharma, AZASAN

"MORREALE MEAT", Beef Recall: JSM Meat Holdings Company Recalls Beef Products.

Another beef recall! Due to E. coli O157:H7 contamination.
Recallr: Beef Recall: JSM Meat Holdings Company Recalls "MORREALE MEAT" An Undetermined Amount Of Beef Products.

Tags: USDA Recall, FSIS Recall, Beef Recall, JSM Meat Holdings Company Recall, E. coli O157:H7, MORREALE MEAT

Get Jump On Your Blog Traffic With Entrecard.

Warning, this post may not help with your health but your blogs health if you are a blogger. One can have all the good information on a blog but it is of no use if people do not see read them. That is the exact reason we joined Entrecard, to attract mo readers, to increase trafic.
If you are a regular visitor to our blog, you have seen the Entrecard widget advertising that we have selected from thousands of other blogs in Entrecard system who wished to advertise on out blog.
But I did not get paid for those ads in money. I got paid in Entrecard credits that I could use to advertise in other blogs I see fit. Another factor is the widget itself is a visiting card. If you happen to visit a Entrecard enabled site, you can drop your card and you will be paid points for that as well.
But why I am today is to let you know that Entrecard is going places and has upgraded the system.
Now all Entrecard members could add more than one blog. You can add all your blogs to Entrecard simply by going to your Dashboard and clicking "Linked Blogs" in your Dashboard navigation. You will be able to choose whether to link your account with another EXISTING account, or to register a NEW BLOG with Entrecard, and automatically link it to your account. You will find all the information about this on this blog post about new features.

The other best thing is the Entrecard Ebook, this ebook will guide you along the way from beginner to expert, to make the best use of Entrecard to increase the traffic to your blog.

Thursday, May 15, 2008

Trasylol and the Publication of the BART Study, Health Canada Comments

In USA,Bayer HealthCare Pharmaceuticals Inc. Removes Remaining Stocks of Trasylol From US Market

OTTAWA - In light of the May 14, 2008 publication in the New England Journal of Medicine of the BART study on the use of Trasylol (the brand name for aprotinin) during high-risk cardiac surgery, Health Canada would like to update Canadians on the status of Trasylol in Canada.

Trasylol is authorized for use during coronary artery bypass grafting (CABG) surgery to help reduce bleeding and the need for blood transfusions. The BART clinical trial included use of Trasylol during higher-risk cardiac surgeries for which Trasylol has not been authorized in Canada. The trial was stopped in October 2007 due to an increased number of patient deaths in the Trasylol group.

On November 5, 2007, Health Canada asked Bayer Inc., the manufacturer of Trasylol, to suspend the marketing of the product in Canada. No other product is authorized in Canada for a similar use. A limited access program was put in place by Bayer, in consultation with Health Canada, to make Trasylol available to physicians who conclude that the benefits outweigh the risks for patients undergoing CABG surgery. The use of Trasylol has significantly declined and no adverse events from this limited access program have been reported to Health Canada since the program was initiated. This program will remain in effect until Health Canada's ongoing safety review is completed.

Health Canada continues to review available safety information on Trasylol and will include the findings of the BART study as part of the review. The Department will convey new safety information to Canadians and health care professionals as necessary.

Media Inquiries:
Health Canada
(613) 957-2983

Public Inquiries:
(613) 957-2991
1-866 225-0709

Information And Safety Issues On Asthma Medications,

Click On The Image To Down Load Printable PDF Version Of the Document

Asthma is a chronic, life-threatening disease that causes the airways to become inflamed or swollen. When people with asthma react to various triggers, such as upper respiratory infections, dust, pollen, or smoke, their airways become narrow. This can cause difficulty breathing, wheezing, chest tightness, or coughing. The two main types of asthma drugs are quick-relief medications that immediately treat sudden symptoms and long-term control medications that are taken regularly to prevent symptoms.

Here is a Food and Drug Administration (FDA) update on recent safety issues with asthma medications.

Incorrect use of Foradil Aerolizer

In February 2008, FDA issued a Public Health Advisory to highlight the correct use of Foradil capsules. Foradil Aerolizer (formoterol fumarate inhalation powder) is approved to prevent wheezing and breathing problems caused by asthma and chronic obstructive pulmonary disease (COPD).

The medication in Foradil capsules is specifically designed to be inhaled through the Foradil Aerolizer inhalation device to deliver the medicine to the lungs. FDA and the American Association of Poison Control Center's National Poison Data System have received reports of people swallowing the capsules rather than placing them in the inhalation device.

Few patients have experienced side effects from swallowing the capsules. But the medication won't work if the capsules are swallowed rather than inhaled. FDA's Public Health Advisory on Foradil also addresses similar incorrect use of Spiriva HandiHaler (tiotropium) capsules, which is approved by FDA to treat COPD.

Advice for patients …
Patients should not swallow the Foradil or Spiriva capsules as the capsules are only to be used with the inhalation device provided with the product. Patients should follow the instructions in the patient information leaflet provided with the product.

The Public Health Advisory: Important Information on the Correct Use of Spiriva and Foradil Capsules, may be found at: www.fda.gov/cder/drug/advisory/tiopropium_formoterol.htm

Suicidality and Behavior/Mood Changes with Singulair

Singulair (montelukast sodium) is approved to treat asthma and symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of nose), and to prevent exercise-induced asthma. Singulair is part of a class of "anti-leukotriene" drugs. These drugs act by blocking the activity of leukotrienes, chemicals that are involved in airway inflammation.

In the past year, Merck & Company, Inc. has updated the patient information for Singulair to include these postmarketing adverse events: tremor, depression, suicidal thinking and behavior (including suicide), and anxiousness.

In March 2008, FDA issued an early communication about an ongoing safety review of Singulair. The agency is investigating a possible association between the use of Singulair and behavior/mood changes, suicidal thinking and behavior, and suicide.

Early communications are in keeping with FDA's commitment to inform the public about its ongoing safety reviews of drugs. An early communication does not mean that FDA has concluded that there is a causal relationship between the drug and the emerging safety issue. It means that FDA is considering the information but has not yet reached a conclusion.

FDA is working with Merck to perform a complex analysis of Singulair data and will communicate the conclusions and recommendations to the public. The agency is also reviewing postmarketing reports it has received of behavior/mood changes, suicidal thinking, and suicide in patients who have taken Singulair as well as other leukotriene modifying medications, such as Accolate (zafirlukast) and Zyflo (zileuton) and Zyflo CR.

Advice for patients …
Patients should not stop taking these medications before talking to their health care professional about this information. FDA urges patients to report side effects from use of these medications to FDA's MedWatch Adverse Event Reporting Program at: http://www.fda.gov/medwatch/report/consumer/consumer.htm

The Early Communication About an Ongoing Safety Review of Montelukast (Singulair) may be found at: www.fda.gov/cder/drug/early_comm/montelukast.htm

Safety of Long-Acting Beta Agonists (LABAs)

Bronchodilators are medications that help open up the breathing tubes, but they do not treat the underlying inflammation of asthma. Short-acting bronchodilators are quick-relief medications used for treatment of asthma symptoms. One example is Albuterol. Long-acting beta2 adrenergic agonists (LABAs) are bronchodilators used to provide long-term control of asthma. Examples of medications that contain LABAs and that are approved for use in asthma patients include Advair Diskus (fluticasone propionate; salmeterol xinafoate), Symbicort (budesonide; formoterol fumarate dihydrate), Serevent Diskus (salmeterol xinafoate), and Foradil.

In 2005, FDA issued a Public Health Advisory that alerted health care professionals and patients that LABA medicines may increase the chance of severe asthma episodes and death when the episodes occur. In this advisory, FDA highlighted several recommendations about LABA drugs. For example, LABAs should not be the first medicine used to treat asthma.

In 2006, the manufacturers of Advair Diskus, Foradil Aerolizer, and Serevent Diskus updated product labels with these warnings. Since that time, several additional products containing LABAs have been approved, including Symbicort, Perforomist (formoterol fumarate), and Brovana (arformoterol tartrate). The labels for these products contain similar warnings regarding severe asthma episodes and death.

At a November 2007 Pediatric Advisory Committee meeting, FDA raised concerns about the safety of LABAs in children with asthma. 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 to further evaluate their safety. Following the analysis of this data, FDA plans to discuss the benefit and risk of LABAs at a public advisory committee meeting later this year.

Advice for patients …
Patients should understand the risks of LABAs and talk with their health care professional about their concerns.

The FDA Public Health Advisory: Advair Diskus, Advair HFA, Brovana, Foradil, Perforomist, Serevent Diskus, and Symbicort Information, may be found at: www.fda.gov/cder/drug/infopage/LABA/default.htm

Anaphylaxis and Xolair

Xolair (omalizumab) is approved for treating moderate to severe persistent asthma related to allergies in patients whose symptoms are not controlled with inhaled corticosteroids. In February 2007, FDA requested that Genentech add a boxed warning to the Xolair product label. The boxed warning emphasizes that Xolair may cause anaphylaxis, an allergic reaction that may include trouble breathing, chest tightness, dizziness, fainting, itching and hives, and swelling of the mouth and throat.

Advice for patients …
It's important to know that patients may develop this reaction after any dose of Xolair, even if there was no reaction to the first dose. Also, anaphylaxis after administration of Xolair may be delayed up to 24 hours or more after the dose is given.

Patients who take Xolair should know the symptoms of anaphylaxis, and should also know how to initiate emergency self-treatment.

The FDA Health Care Professional Alert: Stronger Warning Proposed for Xolair, may be found at: www.fda.gov/cder/drug/infopage/omalizumab/default.htm

7 Ways to Prevent Foodborne Illness, Start At The Store.

Click On The Image To Down Load The PDF Version (printable book) Of This Circular.

Safeguarding your home against foodborne illnesses begins not at home, but at the supermarket, grocery store, or any other place where you buy food that you plan to store and serve.

Combating foodborne illnesses is a top priority at the Food and Drug Administration (FDA). That's because, according to the Centers for Disease Control and Prevention (CDC), foodborne ailments cause about 325,000 hospitalizations and 5,200 deaths nationwide each year.

You as a consumer can play a key role in preventing these illnesses. While shopping for food, you should:

1. Check for cleanliness.

Buying from a retailer who follows proper food handling practices helps assure that the food is safe. Ask yourself: What is the general impression of this facility? Does it look and smell clean?

2. Keep certain foods separated.

Separate raw meat, poultry, and seafood from other foods in your grocery shopping cart. Place these foods in plastic bags to prevent their juices from dripping on other foods. It is also best to separate these foods from other foods at checkout and in your grocery bags.

3. Inspect cans and jars.

Don't buy food in cans that are bulging or dented. Also, don't buy food in jars that are cracked or have loose or bulging lids.

Since foods sold in cans or jars are processed to be sterile, they can "keep" for a long time if the can or jar is intact. A bulging can or jar lid may mean the food was under-processed and is contaminated. A dent in a can, especially if the dent affects a seam, may cause an opening in the seam which may allow contamination, as would a crack in a jar. A loose lid on a jar means the vacuum has been lost and the product may be contaminated. Don't buy a food product whose seal seems tampered with or damaged.

4. Inspect frozen food packaging.

Don't buy frozen food if the package is damaged. Packages should not be open, torn or crushed on the edges. Also, avoid packages that are above the frost line in the store's freezer. If the package cover is transparent, look for signs of frost or ice crystals. This could mean that the food in the package has either been stored for a long time or thawed and refrozen. In such cases, choose another package.

5. Select frozen foods and perishables last.

Meat, poultry, fish and eggs should be the last items placed in your shopping cart. Always put these products in separate plastic bags so that drippings don't contaminate other foods.

6. Choose fresh eggs carefully.

Before putting eggs in your cart, open the carton and make sure that the eggs are clean and none is cracked. Buy only refrigerated eggs and follow the "Safe Handling Instructions" on the carton.

7. Be mindful of time and temperature.

It's important to refrigerate perishable products as soon as possible after grocery shopping. Food safety experts stress the "2-hour rule"—because harmful bacteria can multiply in the "danger zone" (between 40° and 140° F), perishable foods should not be left at room temperature longer than 2 hours. Modify that rule to 1 hour when temperatures are above 90° F, as they often are in cars that have been parked in the sun.

If it will take more than an hour to get your groceries home, use an ice chest to keep frozen and perishable foods cold. Also, when the weather is warm and you are using your car's air conditioner, keep your groceries in the passenger compartment, not the trunk.

Bayer HealthCare Pharmaceuticals Inc. Removes Trasylol From US Market

On Nov. 5, 2007, the U.S. Food and Drug Administration announced that Bayer Pharmaceuticals Corp. agreed to an FDA-requested marketing suspension of Trasylol, a drug used to control bleeding during heart surgery. At that time, preliminary results from a Canadian study suggested an increased risk for death compared to two other drugs used to control bleeding.

Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician’s stock. The FDA will work with Bayer to ensure a smooth and complete process.

Recallr: Bayer HealthCare Pharmaceuticals Inc. Removes Remaining Stocks of Trasylol From US Market

Tags: FDA Recall, Drug Recall, Trasylol recall, Trasylol marketing suspension, Bayer Recall , Trasylol, FDA, Antifibrinolytic drugs, Bayer Pharmaceuticals Corp