Skip to main content

FDA's MedWatch Safety Alerts: August 2009

On this page:

 

After the Food and Drug Administration (FDA) approves a product and it is on the market, FDA continues to monitor unexpected and undesirable side effects (adverse events) of that product.

Health care professionals and consumers may report side effects, product quality problems, product use errors, or therapeutic failure with the use of medical products to FDA's MedWatch Adverse Event Reporting program either online, by fax, or by phone.

MedWatch reports can signal a safety problem and lead to an FDA action to protect the public from harm, serious illness, or even death.

Here are a few of the most recent safety alerts prompted by reports received by FDA from health care professionals and their patients.

 

Recall: Weight-Loss Products

Four weight-loss dietary supplements marketed by Young You Corporation have been recalled:

The products were sold and distributed nationwide via the Internet and at the company’s Weight Loss and Rejuvenation Center in Tarzana, Calif.

The risk: FDA laboratories have found that these products contain sibutramine, which is not declared on the label. Sibutramine is an FDA-approved drug used to curb the appetite for weight loss. FDA has not approved the Young You products as drugs; therefore, the safety and effectiveness of these products are unknown.

Sibutramine is known to substantially increase blood pressure or pulse rate in some people and may be especially dangerous for people with a history of coronary artery disease, congestive heart failure, arrhythmias (disorders of heart rate or rhythm), or stroke.

Recommendations

back to top

 

Recall: Male-Enhancement Products Marketed as Dietary Supplements

The following dietary supplements marketed by Nature & Health Co. have been recalled:

The products were sold in stores in California, Georgia, Illinois, Texas and Ohio.

The risk: FDA laboratories have found that these products contain a drug ingredient of FDA-approved drugs for erectile dysfunction. The ingredient is not declared on the label, making these products unapproved drugs.

The undeclared ingredients in these products may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.

Recommendations

back to top

 

Recall: Infusion Sets Used With Insulin Pumps

Quick-set infusion sets made by Medtronic Inc. that are used with MiniMed Paradigm insulin pumps have been recalled because the infusion sets may not allow the insulin pump to vent air pressure properly. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a person with diabetes.

Affected infusion sets have lot numbers starting with the number “8” and have one of these reference numbers:

The lot number (for example, 8XXXXXX) is clearly marked on both the product box label and on each individual infusion set package.

The risk: The infusion set may deliver too much or too little insulin and may lead to serious injury or death.

Recommendations

back to top

 

Recall: Stealth Chocolate and Stealth Vanilla Powdered Dietary Supplement

The powdered dietary supplement, Stealth Chocolate and Stealth Vanilla, has been recalled because it may be contaminated with the bacteria Salmonella. The product, made by Vital Pharmaceuticals Inc., was distributed nationwide, including GNC Distribution Centers and the VPX Sports Distribution Center, as well as internationally.

The powdered product is packaged in 5-pound blue plastic jars with a red band around the top and bottom of the jar. The label bears the brand name of VPX and STEALTH, Muscle Amplification Lean Mass Gainer, and the flavor Vanilla Blast or Chocolate Rush.

The risk: Salmonella can cause serious infections and even death in young children, frail or elderly people, and others with weakened immune systems.

Recommendations

back to top

 

Recall: Nuby Gel Filled, Cottontails, and Playschool Teethers

Certain teethers made by Luv N’ Care LTD have been recalled because they may contain harmful bacteria in the gel contained in the teether. The teethers affected have the following UPC codes and brand names:

48526-00451 Nuby

48526-00452 Nuby

48526-00453 Nuby

48526-00454 Nuby

48526-00455 Nuby

48526-00459 Nuby

48526-00467 Nuby

48526-00472 Nuby

48526-00473 Nuby

48526-00482 Nuby

48526-00483 Nuby

48526-00487 Nuby

48526-00490 Nuby

48526-00519 Nuby

48526-00521 Nuby

41520-87115 Cottontails

50428-91511 Playschool

41520-91660 Cottontails

The teethers were sold through retail stores nationwide and also on the Internet. They are packaged in a plastic bubble on a printed card.

The risk: The bacteria (Bacillus subtilis and Bacillus circulans) that have been found on the teethers can cause stomach pain, vomiting, and diarrhea in children with weakened immune systems if the teether is punctured and the liquid from the teether is swallowed.

Recommendations

back to top

 

Early Communication on Safety of Xolair

FDA is evaluating safety findings known at this point from an ongoing study of Xolair (omalizumab). Xolair is approved for use by people 12 years of age and older with moderate to severe asthma who react to an airborne allergen year-round and whose symptoms are not controlled well with inhaled corticosteroids.

The risk: These interim findings suggest an increase in adverse events involving the blood vessels of the heart or brain (cardiovascular or cerebrovascular events) in people treated with Xolair compared to another group of people not given the drug.

This type of communication (early communication) is part of FDA's effort to communicate early with the public when the agency is still evaluating data and has not reached a conclusion.

Recommendations:

back to top

 

Warning About Electronic Cigarettes

FDA’s laboratory analysis of electronic cigarette samples found diethylene glycol, a toxic chemical used in antifreeze, and cancer-causing substances (carcinogens). Also known as "e-cigarettes," these battery-operated devices turn nicotine, flavor, and other chemicals into a vapor that is inhaled by the user.

For a full consumer update, see FDA Warns of Health Risks Posed by E-Cigarettes.

back to top

 

Warning About Steroid-Containing Body Building Products

FDA has warned the public about potentially serious health risks associated with body building products that claim to contain steroids or steroid-like substances. Although marketed as dietary supplements, they are unapproved new drugs that have not been reviewed by FDA for safety and effectiveness.

For a full consumer update, see Warning on Body Building Products Marketed as Containing Steroids or Steroid-Like Substances.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Date Posted: August 7, 2009

back to top

Return to FDA Consumer Articles

For more information about food, medicine, cosmetic safety and other topics for your health, visit FDA.gov/consumers.