The FDA has notified healthcare professionals and consumers about new safety information concerning products marketed for body building and increasing muscle mass, frequently marketed as dietary supplement alternatives to anabolic steroids. The FDA has sent a Warning Letter to American Cellular Laboratories, Inc., a manufacturer of body building products that claim to contain steroid-like ingredients, but in fact contain synthetic steroids.  The products named in the Warning Letter include TREN-Xtreme, MASS Xtreme, ESTRO Xtreme, AH-89-Xtreme, HMG Xtreme, MMA-3 Xtreme, VNS-9 Xtreme, and TT-40-Xtreme. Although products containing synthetic steroids are frequently marketed as dietary supplements, they are not dietary supplements, but instead are unapproved new drugs that have not been reviewed by the FDA for safety and effectiveness

Adverse event reports received by the FDA for body building products that are labeled to contain steroids or steroid alternatives include cases of serious liver injury, stroke, kidney failure, and pulmonary embolism. Consumers should immediately stop using all body building products that claim to contain steroids or steroid-like substances and contact their healthcare professional if they are experiencing symptoms possibly associated with these products (eg, nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, jaundice, or brown/discolored urine).

For more information visit www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm173935.htm.