Yesterday, July 28, 2009, the FDA issued a Public Health Advisory recommending that consumers not use certain over-the-counter products marketed as containing “steroid-like ingredients.”
The products in question are manufactured by a company called American Cellular Laboratories, Inc., which markets and sells these products in stores and online as “dietary supplements.” The FDA suspects that these products may contain synthetic steroids and has issued a warning to American Cellular. In its advisory, the FDA lists the following products as examples of products “about which the FDA has safety concerns”: TREN-Xtreme, MASS Xtreme, ESTRO Xtreme, AH-89-Xtreme, HMG Xtreme, MMA-3 Xtreme, VNS-9 Xtreme, and TT-40-Xtreme.
Furthermore, the FDA advises that these products have not been reviewed or approved by the agency and that it views these products not as “dietary supplements,” but rather, as misbranded and unapproved new drugs. FDA Consumer Update. The agency has executed a search warrant on the company to investigate further.
The health risks associated with these products include nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, yellowing of the skin or whites of the eyes, or brown/discolored urine. Also, the FDA is advising healthcare providers to ask patients what over-the-counter supplements they might be using and to be on the lookout for warning signs commonly associated with steroid use, including liver injury, kidney failure, stroke, and hormone-associated adverse effects, such as blood clots, including pulmonary embolism and deep vein thrombosis.