CRN urges consumers to heed FDA warning on Tri-Methyl Xtreme

SILVER SPRING, Md. - The U.S. Food and Drug administration earlier this week warned 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.

 

“We urge consumers to take seriously FDA’s consumer advisory urging people not to use a product for muscle growth that the agency has indicated is linked to serious liver injury. According to the agency, Tri-Methyl Xtreme, distributed by Las Vegas-based Extreme Products Group, claims to contain anabolic steroids, not permitted to be sold in a dietary supplement, making it an adulterated product," stated Steve Mister, president and CEO of the Council for Responsible Nutrition. "Clearly, products like these create a problem — for consumers, and for responsible industry — and our association is continuing to seek ways to support FDA to get these products off the market. At the very least, more robust and more frequent inspections of manufacturers under the existing good manufacturing practices regulations is required."

 

“Products marketed as supplements that contain anabolic steroids pose a real danger to consumers,” stated Charles Lee, 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.