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FDA's MedWatch Safety Alerts: August 2009

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.

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:

  • 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.

Recommendations

  • 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.

 

Recall: Male-Enhancement Products Marketed as Dietary Supplements

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

  • LibieXtreme
  • Y-4ever
  • 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.

Recommendations

  • 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 sales@naturenhealth.com for information on returning the products for a refund.

 

Recall: Infusion Sets Used With Insulin Pumps

WebMD Public Information from the FDA

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