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Body Building Products Containing Unapproved Synthetic Steroids - FDA Issues Warning

January 19, 2010

The FDA issued a warning concerning body-building products which are marketed as containing steroids or steroid-like compounds. The products are often marketed as dietary supplements and alternatives to anabolic steroids with claims they enhance recovery and build muscle mass. These products contain synthetic steroids and do not meet the definition of a dietary supplement. These synthetic steroids have not been reviewed for efficacy and safety by the FDA and are actually unapproved new drugs. The FDA sent a warning letter to American Cellular Laboratories, Inc., naming several of these body-building products including TREN-Xtreme, Mass Xtreme, ESTRO Xtreme, AH-89-Xtreme, HMG Xtreme, MMA-3 Xtreme, VNS-9 Xtreme, and TT-40-Xtreme. Bodybuilding.com has recalled 65 dietary supplement presentations FDA believes contain ingredients that could be considered steroids. IDS Sports recalled their Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mas Tabs, and Ripped Tabs TR products. MuscleMaster.com recalled 17 of their products. The FDA is also investigating similar products from other manufacturers.

Serious adverse events including stroke, pulmonary embolism, liver injury, and kidney failure can occur in patients taking these types of body-building products. Healthcare professionals should inquire about dietary supplement use in their patients. Immediately discontinue use of any body-building products which claim to contain steroids or steroid-like substances and be aware of possible adverse events such as chest pain, abdominal pain, nausea, weakness, fever, shortness of breath, jaundice, or brown or discolored urine. Report adverse events to the FDA Medwatch Adverse Event Reporting Program.

Additional information is available at the following links:

Medwatch Safety Alert:

• http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188957.htm - Bodybuilding.com
• http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm173983.htm
• http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190925.htm
• http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm197834.htm

Press Release:

• http://www.fda.gov/Safety/Recalls/ucm188929.htm- Bodybuilding.com
• http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm174060.htm
• http://www.fda.gov/Safety/Recalls/ucm190446.htm
• http://www.fda.gov/Safety/Recalls/ucm197824.htm

Public Health Advisory:

• http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm173935.htm

FDA Consumer Updates:

• http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm173739.htm

Warning Letter:

• http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm173874.htm

Updated
January 19, 2010; November 18, 2009; November 4, 2009; July 30, 2009; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.