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FDA Expands Weight-Loss Products Safety Alert

Agency says some contain prescription-only drugs that can harm consumers

FRIDAY, March 20, 2009 (HealthDay News) -- An expanded nationwide alert about tainted weight-loss products that contain undeclared, active pharmaceutical ingredients was announced Friday by the U.S. Food and Drug Administration.

Products added to the alert are Herbal Xenicol, Slimbionic and Xsvelten, and the undeclared pharmaceutical ingredients added to the warning are fenproporex, fluoxetine, furosemide and cetilistat.

The FDA warned consumers late last year not to purchase or consume 28 different products marketed for weight loss. The latest warning is the second update to that list, which now includes 72 products, and the agency said it would continue to update the list as needed.

"These tainted weight-loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed maximum recommended dosages," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a news release. "Consumers have no way of knowing that these products contain dangerous drugs that could cause serious consequences to their health."

The products included in the alert -- some of which are marketed as dietary supplements -- are promoted and sold on various Web sites and in some retail stores and beauty salons, the FDA said. The products have not been approved by the FDA and are illegal, the agency said.

The active pharmaceutical ingredients contained in the products but not identified, the FDA said, include:

  • fenproporex -- a controlled substance not approved for sale in the United States
  • fluoxetine -- an antidepressant available by prescription only
  • bumetanide -- a potent diuretic available by prescription only
  • furosemide -- a potent diuretic available by prescription only
  • rimonabant -- a drug not approved for sale in the United States
  • cetilistat -- an experimental obesity drug not approved for sale in the United States
  • phenytoin -- an anti-seizure medication available by prescription only
  • phenolphthalein -- a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for sale in the United States

More information

A complete list of the tainted weight-loss products is available at the FDA.

SOURCE: U.S. Food and Drug Administration, news release, March 20, 2009
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