FDA Issues Liver Injury Alert for Muscle-Building Supplement

FDA Warning Over Muscle-Building Supplement. The Food and Drug Administration (FDA) has issued a warning to consumers not to use the muscle-growth supplement Tri-Methyl Xtreme. The supplement has been linked to cases of severe liver injury.

Tri-Methyl Xtreme is distributed by Extreme Products, a Las Vegas company, the Wall Street Journal reports. The product is marketed as a dietary supplement but claims to contain anabolic steroids. These chemicals “may have a range of serious adverse effects on many organ systems, and the damage may be irreversible,” according to Dr. Charles Lee of the FDA drug center’s office of compliance. The product is sold online, in some retail stores, and through gyms.

In addition to organ damage, anabolic steroids can raise cholesterol levels, increase the risk of heart attack and stroke, cause women to develop masculine characteristics, and cause male infertility, the FDA warned. This alert is the latest in a series of recent events involving the dietary supplement industry, according to the WSJ.

A newly published study by Harvard Medical School assistant professor, Dr. Pieter Cohen, and colleagues, reports that many supplements listing the plant acacia rigidula on their labels actually contain the amphetamine-like stimulant BMPEA. Though the FDA discovered this in 2013, it did not publicly identify the products or issue a consumer alert, and the agency has come under criticism for its failure to act.

Unlisted Potential Allergens

In another blow to the dietary supplement industry, New York Attorney General Eric Schneiderman found that only 21 percent of herbal supplements sold by four major retailers actually contained the plants listed on the labels. Supplements that supposedly contained echinacea, ginseng, St. John’s wort, garlic, Ginkgo biloba, and saw palmetto, actually contained a range of substances including rice, beans, pine, citrus, asparagus, primrose, wheat, house plants and wild carrots, the WSJ reports. Some of the unlisted substances are potential allergens and could pose risks to consumers who are not aware of their presence in the supplement.

In an April 13 news release, the FDA said it has received reports of adverse events associated with Tri-Methyl Xtreme, from California, New Jersey and Utah. To date, there are no reports of deaths associated with the product. The FDA advised consumers to seek medical attention if they experience such symptoms as unexplained fatigue, abdominal or back pain, discolored urine or other unexplained health changes.

The FDA cautioned consumers about products claiming to be “alternatives” to products already approved by the agency, or “legal” alternatives to anabolic steroids. In addition, the agency said consumers should be skeptical about products with labeling only in a foreign language, or products marketed through mass emails, according to the WSJ. The FDA said that in recent years it has warned consumers about more than 80 products marketed for sexual enhancement, more than 70 weight-loss products, and more than 80 marketed for bodybuilding.

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