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FDA issues another warning over sibutramine contamination

By Hank Schultz contact

- Last updated on GMT

FDA photo
FDA photo
The US Food and Drug Administration has issued a consumer alert on a supplement-like weight loss product because of sibutramine contamination.

FDA announced the alert today after finding the tainted product, marketed as Detoxi Slim, in an examination of international mail shipments.

The product in packaged in a way similar to dietary supplements—capsules in a bottle—but does not appear to have a supplements facts panel. The product appears to be made in Thailand and includes Thai script on the label.

 It is said to contain psyllium husk, chromium, CLA, green tea extract and white bean extract. But FDA found it is in fact adulterated with sibutramine, which at one time was marketed in the United States by Abbott Laboratories as a prescription weight loss aid under the brand name Meridia.  It was removed from the market in 2010 over health concerns.

According to FDA, the product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or heart rate in some people and may present a significant risk for people with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.

Sibutramine is one of the most frequently appearing drug ingredients in products marketed as dietary supplements. Other frequent members of the rogue’s gallery of active pharmaceutical ingredients used to adulterate products marketed as supplements include analogues of the various erectile dysfunction drugs on the market such as Viagra and Cialis.

Related topics: Regulation, Adulteration, Weight management

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