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FDA Issues Another Diet Supplement Warning, Expands List of Dangerous Products

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The U.S. Food and Drug Administration (FDA) has added more  products to its list of dangerous tainted weight loss products. The agency said all of the products on the list are made with undeclared, active pharmaceutical ingredients.

According to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, “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.  Consumers have no way of knowing that these products contain dangerous drugs that could cause serious consequences to their health.”

The FDA said that it has inspected a number of companies associated with the sale of these illegal products and is currently seeking product recalls; however, based on its inspections and the companies’ inadequate responses to recall requests, it may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions, or criminal charges.

The FDA is advising consumers who have used any products containing these ingredients to stop taking them and consult their health care professional immediately and is also urging consumers to seek guidance from a health care professional before purchasing weight loss products.  The health risks posed by these products can be very serious and include high blood pressure, seizures, tachycardia (rapid heartbeat), palpitations, heart attack, and stroke.

The FDA has identified additional weight loss products—Herbal Xenicol, Slimbionic, and Xsvelten—as well as new, undeclared active pharmaceutical ingredients—fenproporex, fluoxetine, furosemide, and cetilistat in this warning.

The FDA explained that on December 22, 2008 it warned consumers not to purchase or consume 28 different products marketed for weight loss and that on January 8, 2009 it expanded that list to include 41 additional tainted products.  The list now includes 72 tainted products. Some of these tainted products are marketed as dietary supplements, some are promoted and sold on various Websites, and some are sold in retail stores and beauty salons.  Also, some products claim to be “natural” or to contain only “herbal” ingredients, but actually 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:  Fenproporex, a controlled substance not approved for marketing in the United States; fluoxetine, an antidepressant available by prescription only; bumetanide and/or furosemide, are potent diuretics available by prescription only; rimonabant, a drug not approved for marketing in the U.S.; cetilistat, an experimental obesity drug not approved for marketing in the U.S.; phenytoin, an anti-seizure medication available by prescription only; and phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent not approved for marketing in the U.S.

Sibutramine, a controlled substance, was found in many of these products at levels much higher than the maximum daily dosage for Meridia, the only FDA-approved drug product containing sibutramine.  These higher levels of sibutramine can increase the incidence and severity of these health risks.  Fenproporex, another controlled substance, can cause arrhythmia and possible sudden death.

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