FDA advises against use of body-building products containing steroids or steroid-like substances

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The Food and Drug Administration issued a public health advisory today warning consumers to stop using body-building products that are marketed as containing steroids or steroid-like substances.

The FDA has received reports of ‘serious adverse events’ associated with the use of these products, including serious liver injury, stroke, kidney failure and pulmonary embolism (artery blockage in the lung). The agency advises consumers to stop ingesting body-building products -- no matter who is the manufacturer -- that claimto contain steroid-like substances or to enhance or diminish androgen-, estrogen-, or progestin-like effects in the body.

The agency also issued a warning letter to American Cellular Laboratories Inc. for marketing and distributing body-building products containing synthetic steroid substances. The FDA said that although these products are marketed as dietary supplements, they are actually unapproved and misbranded drugs.

The FDA has received five adverse-event reports, including serious liver injury, in men taking products marketed as dietary supplements by American Cellular Laboratories including TREN-Xtreme and MASS Xtreme. Acute liver injury is known to be a possible side effect of using products that contain anabolic steroids. Some of the cases resulted in hospitalization, but there were no reports of death or acute liver failure.

“Products marketed for body-building and claiming to contain steroids or steroid-like substances are illegal and potentially quite dangerous,” said Commissioner of Food and Drugs Margaret A. Hamburg. “The FDA is taking enforcement action today to protect the public.”

The products listed in the warning letter to American Cellular Laboratories include “TREN-Xtreme,” “MASS Xtreme,” “ESTRO Xtreme,” “AH-89-Xtreme,” “HMG Xtreme,” “MMA-3 Xtreme,” “VNS-9 Xtreme,” and “TT-40-Xtreme,” and are sold on the Internet and in some stores. These products, which claim to contain steroid-like ingredients but in fact contain synthetic steroid substances, are unapproved new drugs because they are not generally recognized as safe and effective. In addition, the products are misbranded because the label is misleading and does not provide adequate directions for use.

Consumers taking body-building supplements that claim to contain steroids or steroid-like substances should stop using them immediately. Consumers should also consult a healthcare professional if they suspect they are experiencing problems associated with the products. Healthcare professionals and consumers are encouraged to report adverse events that may be related to the use of these types of products to the FDA’s MedWatch Program by calling (800) FDA-1088.

-- Andrea Chang