FDA warns consumers not to use muscle growth product called Tri-Methyl Xtreme

The U.S. Food and Drug administration is warning consumers to stop using a dietary supplement for muscle growth linked to serious liver injury.

Tri-Methyl Xtreme, distributed by Las Vegas-based Extreme Products Group, claims to contain anabolic steroids and is sold on the Internet and in some retail stores and gyms.

An investigation is underway by the FDA to identify the product’s manufacturer after the agency received adverse event reports from consumers—one each from California, New Jersey and Utah. The agency has not received reports of death from use of the product.

“Products marketed as supplements that contain anabolic steroids pose a real danger to consumers,” said Charles Lee, M.D., a senior medical advisor in the FDA’s Center for Drug Evaluation and Research’s Office of Compliance. “Anabolic steroids may have a range of serious adverse effects on many organ systems, and the damage may be irreversible.”

Liver injury is generally known to be a possible outcome of using products that contain synthetic anabolic steroids, and steroid-like substances.  In general, anabolic steroids may cause other serious long-term consequences, including adverse effects on cholesterol levels; increased risk of heart attack and stroke; masculinization of women; shrinkage of the testicles; breast enlargement; infertility in males; and short stature in children.

Consumers who suspect they are experiencing problems associated with Tri-Methyl Xtreme or other body building products should consult a health care professional, especially if they have experienced unexplained fatigue, abdominal or back pain, discolored urine or any other unexplained changes in their health.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download the form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178