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FDA Warns of Tainted Diet Pills

25 products could lead to heart problems, depression, and worse

December 23, 2008
The Food and Drug Administration (FDA) on Monday warned consumers not to buy more than 25 products marketed for weight loss because they pose serious health risks.

The agency said it is trying to recall the products, which contain ingredients not approved for use in the United States or pose such health risks as high blood pressure, seizures, or strokes.

The weight loss products — tainted with what the FDA calls "undeclared active pharmaceutical ingredients" — are: Fatloss Slimming, Japan Lingzhi 24 Hours Diet, 2 Day Diet, 3x Slimming Power, 5x Imelda Perfect Slimming, 3 Day Diet, 7 Day Herbal Slim, 8 Factor Diet, 7 Diet Day/Night Formula, 999 Fitness Essence, Extrim Plus, GMP, Imelda Perfect Slim, Lida DaiDaihua, Miaozi Slim Capsules, Perfect Slim, Perfect Slim 5x, Phyto Shape, ProSlim Plus, Royal Slimming Formula, Slim 3 in 1, Slim Express 360, Slimtech, Somotrim, Superslim, TripleSlim, Zhen de Shou, and Venom Hyperdrive 3.0.

These products are sometimes marketed as "dietary supplements," and sold on various Web sites and in retail stores. Some of the products claim to be "natural" or contain only "herbal" ingredients.

An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include sibutramine, a controlled substance; rimonabant, a drug not approved for marketing in the United States; phenytoin, an anti-seizure medication; and phenolphthalein, a solution used in chemical experiments and a suspected cancer causing agent.

The amount of some of these ingredients far exceeds the levels recommended by the FDA — and puts consumers' health at risk.

Sibutramine, for example, can cause high blood pressure, seizures, tachycardia, palpitations, heart attack, or stroke. This drug, which was found in many of the products, can also interact with other medications and increase patients' risk of adverse drug reactions, the FDA said.

Rimbonant, which is approved in Europe, has been associated with increased risk of depression and suicidal thoughts. It is also linked to five deaths and 720 adverse reactions in Europe over the last two years, the FDA said.

The FDA warned consumers who use any of these products to immediately stop taking them and contact their physician.

"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 their maximum recommended dosages," said Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA. "Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences. Therefore FDA is taking this action to protect the health of the American public."

The FDA, which has inspected several companies that sell these products, is now trying to pull them off the market.

"Based on the FDA's inspections and the companies' inadequate responses to recall requests, the FDA may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions, or criminal charges," the FDA said.

The agency encouraged health care professionals and consumers to report any serious side effects or other problems associated with these products to the FDA's MedWatch Adverse Event Reporting program.

They can also call the FDA at (800) FDA-1088 or send a letter to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787. The agency offers a postage-paid form for contact by mail.

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