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FDA Warns about Additional Tainted Weight-loss Products
The FDA is again expanding a nationwide alert to consumers about weight-loss products containing undeclared, active pharmaceutical ingredients.
The FDA has identified additional weight loss products (Herbal Xenicol, Slimbionic, and Xsvelten) and new undeclared active pharmaceutical ingredients (fenproporex, fluoxetine, furosemide, and cetilistat). For an updated list, see www.fda.gov/bbs/topics/NEWS/2009/NEW01977.html.
On Dec. 22, 2008, the FDA warned consumers not to purchase or consume 28 different products marketed for weight loss. On Jan. 8, 2009, the FDA expanded the list of tainted weight-loss products to include 41 additional tainted products. The list now includes 72 products, and the FDA will continue to update this list as warranted.
"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," says Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, in a statement. "Consumers have no way of knowing that these products contain dangerous drugs that could cause serious consequences to their health."
The tainted products may contain potentially harmful ingredients not listed on the products' labels or in promotional advertisements. These products have not been approved by the FDA, are illegal, and include the following undeclared active pharmaceutical ingredients:
Sibutramine: an appetite suppressant available by prescription only and a controlled substance);
Fenproporex: a controlled substance not approved for marketing 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 marketing in the United States;
Cetilistat: an experimental obesity drug not approved for marketing in the United States;
Phenytoin: an antiseizure medication available by prescription only;
Phenolphthalein: a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States.
The FDA advises consumers who have used any products containing these ingredients to stop taking them and consult their health care professionals immediately. Health care professionals and consumers should report serious adverse events or product quality problems to the FDA's MedWatch Adverse Event Reporting program.