FDA Warns Against Dietary Supplement Venon HYPERDRIVE 3.0
The U.S. Food and Drug Administration issued a warning today advising consumers not to take Venom HYPERDRIVE 3.0.
Venom HYPERDRIVE 3.0 is a product sold as a dietary supplement found to contain sibutramine. Sibutramine, a controlled substance available in the United States by prescription which carries the risk of abuse or addiction.
Sibutramine is the active ingredient in an FDA-approved prescription drug used as an appetite suppressant for weight loss. It can substantially increase blood pressure and heart rate. This potent drug poses a significant health risk for anyone with a history of heart disease, heart failure, heart arrhythmias (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, the FDA laboratory tests showed that Venom HYPERDRIVE 3.0 contains a significant amount of sibutramine per dosage unit.
The product has been 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. Contact your health care professional if you 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.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.
* Online: www.fda.gov/MedWatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
* Fax: (800) FDA-0178
* Phone: (800) FDA-1088
For an updated list of all tainted weight loss products, go to: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01933.html.
FDA News Release