FDA Warns Consumers Against Dietary Supplement Containing Undeclared Drug

The Food and Drug Administration is warning consumers not to take Venom HYPERDRIVE 3.0, a product sold as a dietary supplement and containing sibutramine, a controlled substance with risks for abuse or addiction and poses potential safety risks.

"Sibutramine is the active ingredient in an FDA-approved prescription drug used as an appetite suppressant for weight loss," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "But when present in a dietary supplement, it may harm unsuspecting consumers because sibutramine can substantially increase blood pressure and heart rate (pulse), and may present a significant risk for people with a history of heart disease, heart failure, irregular heart beats, or stroke."

Venom HYPERDRIVE 3.0 is marketed by Applied Lifescience Research Industries Inc. (ALR Industries), Oak View, Calif. On Dec. 24, 2008, ALR Industries initiated a recall of all lots of Venom HYPERDRIVE 3.0 after the FDA laboratory analysis showed samples of the product contained undeclared sibutramine. Although ALR Industries claims on its Web site that only "trace amounts" of sibutramine were found in this product, FDA laboratory tests showed that Venom HYPERDRIVE 3.0 contains a significant amount of sibutramine per dosage unit.

The product was sold via distributors and in retail stores nationwide as well as in Canada, Poland, Sweden, Hungary, South Africa, the Netherlands, Australia, France, and the United Kingdom. The product was packaged in red plastic bottles containing 90 capsules each with the UPC# 094922534743.

Consumers who have this product should stop taking it immediately and contact their health care professional if they have experienced any adverse effects. Consumers can contact the company at [email protected] to receive further instructions for returning the product and to ask any questions.

For an updated list of all tainted weight loss products, go to www.fda.gov/bbs/topics/NEWS/2008/NEW01933.html.

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