FDA Warning: Venom Hyperdrive 3.0 Contains An Undeclared DrugJan 28, 2009 | Parker Waichman LLP
The U.S. Food and Drug Administration (FDA) just issued a warning to consumers regarding a so-called dietary supplement that contains an undeclared drug. The FDA is advising consumers not to take Venom HYPERDRIVE 3.0, a product sold as a dietary supplement and which contains the controlled, potent substance sibutramine, which has risks for abuse or addiction and which poses potential safety and health 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) of Oak View, California and is sold as a fat burner for use in achieving weight loss. Following an FDA laboratory analysis of Venom HYPERDRIVE 3.0, the agency discovered that the samples tested revealed that the product contained undeclared sibutramine. ALR Industries initiated a recall on December 24, 2008 of all lots of its Venom HYPERDRIVE 3.0 following the information released by the FDA.
Meanwhile, ALR Industries claims on its Website that only "trace amounts" of sibutramine were found in this product; however, FDA testing revealed Venom HYPERDRIVE 3.0 contains a significant amount of sibutramine per dosage unit. This is not the first time a dietary supplement has been found to contain undeclared, dangerous drugs. For an updated listing, the FDA maintains an updated page on its Website that details all tainted weight loss products at: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01933.html.
Venom HYPERDRIVE 3.0 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. Venom HYPERDRIVE 3.0 was packaged in red plastic bottles containing 90 capsules each with the UPC# 094922534743.
The FDA is warning consumers who have this product to stop taking it immediately and contact their health care professional if they have experienced any adverse effects. Consumers can contact ALR Industries at firstname.lastname@example.org to receive further instructions for returning the product and to ask any questions.
The FDA is also advising health care professionals and consumers to 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, as follows: Online: www.fda.gov/MedWatch/report.htm; regular mail: use postage-paid FDA form 3500 available online at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787; by Fax at: (800) FDA-0178; or by telephone, toll-free at: (800) FDA-1088.