Product poses safety risk
The U.S. Food and Drug Administration is warning 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
"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, 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 health care professional if they have experienced any
adverse effects. Consumers can contact the company at email@example.com 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.
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.
FOR IMMEDIATE RELEASE
January 27, 2009
Christopher Kelly, 301-796-4676