Thursday, July 30, 2009

FDA Advises Consumers Not to Use Body-Building Supplements that Contain Steroids


The FDA notified consumers and healthcare professionals yesterday not to use body-building products marketed as containing steroids or steroid-like substances. The products are marketed for increasing muscle mass and body building and are advertised as alternatives to anabolic steroids. The FDA warns that these products are marketed as dietary substances, but they are instead unapproved new drugs that have not been reviewed by the FDA for safety and effectiveness.

“Products marketed for body building and claiming to contain steroids or steroid-like substances are illegal and potentially quite dangerous,” said the FDA’s commissioner, Dr. Margaret Hamburg. The agency cent a letter to American Cellular Laboratories Inc., saying it markets and distributes drugs labeled as dietary supplements which are in fact unapproved drugs. To be a dietary supplement, a product has to contain one or more dietary ingredients, such as vitamins or minerals.

Over the past two years, the FDA has received 5 adverse event reports through its MedWatch reporting system directly related to steroid containing products. Some of the events reported include serious liver injury. No deaths were reported. The products affected by the warning are marketed by American Cellular Laboratories, Inc. and include: TREN-Xtreme, ESTRO Xtreme, AH-89-Xtreme, HMG Xtreme, MMA-3 Xtreme, VNS-9 Xtreme, and TT-40 Xtreme.

For more information, see the FDA News Release at:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm174060.htm

See the MedWatch Safety Information at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm173983.htm

See the FDA Consumer Report at:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm173739.htm

See the article from CNN’s Website at:
http://www.cnn.com/2009/HEALTH/07/28/body.building.steroids/index.html?eref=rss_health

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posted by Colleen at 6:04 AM

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