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FDA Warning for Weightloss Supplements

Johns Hopkins University
By Simeon Margolis, M.D., Ph.D. - Posted on Tue, Jan 06, 2009, 7:45 pm PST

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On December 22, the Food and Drug Administration (FDA) issued a nationwide alert warning consumers not to buy or consume any of more than 25 products sold as weightloss supplements over the Internet and in some retail stores.

The FDA advises that everyone who has already purchased any of these substances should immediately stop taking them and consult their health care professional, because the supplements pose serious health risks. The names of these weightloss products can be found in the December 22, 2008 news release on the FDA's Web site.

With 2 out of 3 Americans either obese or overweight, unscrupulous companies can make large profits by marketing "diet aids" to this huge group of unwary consumers.

These products all contain undeclared active pharmaceutical agents, including sibutramine (a weight-loss drug that is a controlled substance), rimonabant (a weight-loss drug not approved in the United States), phenytoin (an anti-seizure medication), and phenolphthalein (an agent suspected of causing cancer).

As mentioned above, many of the products in this latest FDA list contain sibutramine, which can cause high blood pressure, seizures, rapid heartbeat, palpitations, heart attack, or stroke. The drug can also increase the risk of adverse events by interacting with other medications that you might already be taking. And the safety of sibutramine has not been established in pregnant and lactating women, or in children under the age of 16.

Although rimonabant is approved for use in Europe, the FDA rejected its marketing here in the U.S. because studies carried out by its manufacturer have reported that the drug has been associated with an increased risk of depression and suicidal thoughts. Over the last 2 years, rimonabant has also been linked to 5 deaths and 720 adverse reactions in Europe.

I have repeatedly warned that weight-loss dietary supplements do not work and can be dangerous. Last November, the FDA removed some weightloss pills from the market, and the agency will again be working to ban the sales of the pills on this new dangerous-product list.

The FDA has in fact approved two weight-loss drugs—orlistat (Xenical®), now available over the counter as Ali®, and sibutramine (Meridia®), which requires a prescription. But even these two medications bring about only modest weight loss: There is no avoiding the fact that weight loss takes hard work—eating fewer calories and exercising more.

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