FDA issues warning for ALR dietary supplement

ROCKVILLE, Md. The Food and Drug Administration Tuesday afternoon warned consumers not to take Venom HYPERDRIVE 3.0, a product sold as a dietary supplement and containing sibutramine. Sibutramine, a controlled substance with risks for abuse or addiction, is a potent drug that poses potential safety risks, the agency stated.

“Sibutramine is the active ingredient in an FDA-approved prescription drug used as an appetite suppressant for weight loss,” stated Janet Woodcock, director of 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 … and may present a significant risk for people with a history of heart disease, heart failure, irregular heartbeats or stroke.”

Venom HYPERDRIVE 3.0 is marketed by Applied Lifescience Research. On Dec. 24, ALR 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, the 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 healthcare professional if they have experienced any adverse effects.