FDA's MedWatch Safety Alerts: August 2009
- Recall: Weight-Loss Products
- Recall: Male-Enhancement Products Marketed as Dietary Supplements
- Recall: Infusion Sets Used With Insulin Pumps
- Recall: Stealth Chocolate and Stealth Vanilla Powdered Dietary Supplement
- Recall: Nuby Gel Filled, Cottontails, and Playschool Teethers
- Early Communication on Safety of Xolair
- Warning About Electronic Cigarettes
- Warning About Steroid-Containing Body Building Products
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 regular mail, by fax, or by phone.
- Regular Mail: Use postage-paid FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.
- Fax: 1-800-FDA-0178
- Phone: 1-800-332-1088
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.
Four weight-loss dietary supplements marketed by Young You Corporation have been recalled:
- Slimbionic, 30 capsules/box
- One Weight Loss Pill, 30 capsules/bottle
- SlimDemand Capsules, 30 capsules/box
- Botanical Weight Loss, 30 capsules/box
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.
- Destroy these products or return them to Young You at 19590 Ventura Blvd., Tarzana, CA 91356.
- Contact Young You Corporation at 818-344-3344 for more information.
The following dietary supplements marketed by Nature & Health Co. have been recalled:
- Libimax X Liquid
- Powermania Liquid and Capsule
- Herbal Disiac
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.
- Stop using these products immediately.
- Contact your health care professional if you have experienced any problems that may be related to taking these products.
- Contact Nature & Health at (714) 671-0016 or at firstname.lastname@example.org for information on returning the products for a refund.
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.
- Stop using “Lot 8” Quick-set infusion sets.
- Return any affected infusion sets to the company, which will replace them at no additional charge. For more information, see Medtronic's Web page or call Medtronic at 800-345-8139.
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.
- Return the product to the store where you bought it for a refund.
- Call Vital Pharmaceutical Inc. at 800-954-7904 or 954-641-0570 for more information.
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:
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.
- Stop using the teethers immediately.
- Throw the teethers out or return them to the store where you bought them for a refund.
- Contact Luv N’ Care LTD at 1-800-256-2399 ext. 3106 for more information.
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.
- Do not stop taking Xolair without the advice of your health care professional.
- Talk with your health care professional about the risks and benefits described in the prescribing information for Xolair, as well as the new information from the ongoing study, called EXCELS.
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.
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