FDA Says Beware of Venom HYPERDRIVE 3.0, a Potent
Drug with Safety Risks for Many Seniors
Seniors should know ingredient can substantially
increase blood pressure, heart rate (pulse), and may present significant
risk for those with a history of heart disease, heart failure,
irregular heart beats or stroke
Feb. 2, 2009 If the name Venom HYPERDRIVE 3.0
doesnt scare you, it should, says the U.S. Food and Drug
Administration. The FDA 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 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, 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
legal@alrindustries.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.
● 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.
