The Most Recent FDA Alerts on Medications, Recalls And Overall Health Concerns and Warnings.

The Following information is broken down by the weeks with the most recent showing first. This is updated when new information is made available. Also, make sure you read up on the Drug Versus Generic information here

February 04, 2008

Helping Patients Avoid Counterfeit Drugs
over the Internet
FDA has previously warned about the risks of buying drugs and other medical products over the Internet. Products bought on the Internet could be fake, sub-potent, or not approved by the FDA. They could also be counterfeit.

FDA recently discovered two different web sitesselling a counterfeit version of the weight-loss drug Xenical. In one case, it actually contained another drug, and other samples contained just starch and talc. And that is just one example of the risks people take if they buy drugs over the internet.

An article in a recent issue of "Family Practice Management" gives several tips that practitioners can give to patients to help avoid counterfeit products. One is to advise patients to use only U.S. sites that are licensed by a State board of pharmacy. Some of these sites display the VIPPS seal, which stands for Verified Internet Pharmacy Practice Site. The National Association of Boards of Pharmacy gives the seal to Internet pharmacies that meet State licensure and other criteria.

The article lists some of the drugs that are most susceptible tocounterfeiting and points outs that counterfeiters tend to favor
expensive drugs that are sold in large volume, e.g.,
anti-cholesterol medications. The article notes that so-called "embarrassment drugs" are widely counterfeited i.e., drugs for conditions that patients may be reluctant to discuss with their doctors. This would include drug such as Viagra, Cialis and Propecia.

FDA Takes Actionto Stop the Marketing of Unapproved Injectable Drugs ContainingColchicine

The U.S. Food and Drug Administration today announced itsintention to take enforcement action against companies marketing unapproved injectable colchicine, a drug used to treat gout.

Colchicine is a highly toxic drug that can easily beadministered in excessive doses, especially when given intravenously. There is a narrow margin between an effective dose of the drug and a toxic dose that can result in serious health risks, including death. The FDA is aware of 50 reports of adverse events associated with the use of intravenous colchicine, including 23 deaths. Potentially fatal effects include lowblood cell counts, cardiac events, and organ failure.

FDAInvestigation Leads to Several Indictments for Importing Contaminated Ingredients Used in Pet Food
Contaminated pet food causedpet illnesses and deaths last year

Melamine can be used to create products such as plastics,cleaning products, glues, inks, and fertilizers. Under certainconditions, melamine mixed with wheat gluten can make the productappear to have a higher protein level than is actually present.Melamine has no approved use as an ingredient in human or animal food in the United States. Wheat gluten is a natural protein derived from wheat or wheat flour, which is extracted to yield a powder with high protein content. Pet food manufacturers often use wheat gluten as a thickener or binding agent in the manufacture of certain types of pet food.

Generic FosamaxApproved

FDA NotifiesPublic of Adverse Reactions Linked to Botox Use

The U.S. Food and Drug Administration today notified thepublic that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.

In an early communication based on the FDA's ongoing safetyreview, the agency said the reactions may be related to overdosing. There is no evidence that these reactions are related to any defect in the products.

The adverse effects were found in FDA-approved and nonapproved
usages. The most severe adverse effects were found in children treated for spasticity in their limbs associated with cerebral palsy. Treatment of spasticity is not an FDA-approved use of botulism toxins in children or adults.

OngoingReview of Cholesterol Drug Vytorin

VitalFacts About HIV Home Test Kits

This product is a kit marketed as either "The Home Access HIV-1 Test System" or "The Home Access Express HIV-1 Test System." The kit is a home collection-test system that requires users to collect a blood specimen, and then mail it to a laboratory for professional testing. No test kits allowconsumers to interpret the results at home. 

class="headBasicCenter">WarningAbout Contaminated Pre-Filled SyringesFDA has announced a nationwide recall of all lots of heparin and salinepre-filled flush syringes manufactured by AM2 PAT, Inc., of Angier,N.C. Two lots have been found to be contaminated with Serratiamarcescens, a bacterium that can cause serious injury ordeath.

The Centers for Disease Control and Prevention has confirmed growth of Serratiamarcescens from unopened heparin syringes.

• Consumers and health care facilities with any of therecalled,pre-filled Heparin Lock or Normal Saline IV Flush syringes should stopusing the product immediately.
• Healthcare facilities should immediately quarantine the products in theirinventory and return them to their distributor.
• Individualconsumers should return them to the location from which they werereceived, such as a pharmacy or hospital.
• Consumers also should let their health care providers knowthat they have been exposed to syringes recalled by FDA.
• Consumerswith questions may contact Sierra Pre-Filled at 919-552-9689, Mondaythrough Friday, 10 a.m. to 5 p.m. EST.
• Report anyadverse reactions experienced with the use of the products, and/orquality problems to FDA's MedWatch Program by phone at 800-FDA-1088, byfax at 800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane,Rockville, M.D. 20852-9787