FDA Issues Expanded Alert for 72 Weight Loss Products

The Weight Loss Products Could Cause Serious or Fatal Health Events

The Food and Drug Administration (FDA) has issued an expanded, nationwide alert to primary care physicians and consumers regarding 72 weight loss products, including Herbal Xenicol, Slimbionic, and Xsvelten.

The weight loss products have been found to contain undeclared, active pharmaceutical ingredients specifically fenproporex, fluoxetine, furosemide, and cetilistat.

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

The products, listed on the FDA website, are promoted and sold on various Web sites and in some retail stores and beauty salons. Some of the 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:

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 anti-seizure medication available by prescription only; and

phenolphthalein – a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States.

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.

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.

MARCH-22-09: FDA Uncovers Additional Tainted Weight Loss Products [FDA: EXPANDED ALERT FOR TAINTED WEIGHT LOSS PRODUCTS]

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Published on Mar-23-09