RAD-140

TUESDAY, May 2, 2023 -- The U.S. Food and Drug Administration is once again warning consumers to avoid muscle-building "supplements" that are anything but a safe alternative to steroids. In an advisory sent out last week, the agency said it continues to receive reports of serious side effects linked to selective androgen receptor modulators (SARMs). The compounds mimic some of the effects of testosterone, and have long been under study for treating muscle-wasting and bone loss caused by certain medical conditions. None have been approved by the FDA, however, and the agency stresses that SARMs are drugs, not dietary supplements. Still, online companies are marketing SARM-containing products, with the help of social media. "Online vendors and social media influencers are using social media to make SARMs seem safe and effective," the FDA said in its warning. Based on the reports the agency is receiving, that is far from the case: SARM-containing products are linked to sometimes life-threatening effects such as heart attacks, strokes and liver failure. Other side effects include testicular shrinkage, sexual dysfunction, fertility problems and even psychosis. The FDA has been warning consumers about the risks for years, and taken action against some companies that illegally market the products. But, experts said, because people are getting SARMs online from overseas companies, the problem is hard to tackle from the supply side. And from the consumer side, it may be just as tough. Contrary to popular belief, the typical SARM user is not a high-level athlete trying to "cheat," said Dr. Shalender Bhasin , director of the Research Program in Men's Health at Brigham and Women's Hospital in Boston. "Most people using SARMs are young men who want to enhance their appearance." And that, according to Bhasin, points to a broader, little-recognized issue: rising rates of body-image disorders among teenage boys and young men. Bhasin said that compared with decades ago, the "idealized male body" these days is improbably lean and muscled -- another message amplified by social media. "These young men are trying to mimic what is not realistic -- something you can't achieve by going to the gym a few times a week," Bhasin said. "I worry about young people getting these messages," he added. Dr. Richard Auchus , an endocrinologist and professor at the University of Michigan, agreed that in light of all of that, it may be hard to dissuade SARM users. But there are plenty of reasons to avoid the products, Auchus said. "There are the risks of the SARMs themselves," he said. "And there are the risks of using any product not regulated by the FDA." It's known, Auchus noted, that unregulated products sold as supplements often do not contain what's on the label -- and, more concerning from a health standpoint, may have substances that are not disclosed. In fact, Bhasin found that to be true of SARMs in a 2017 study published in the Journal of the American Medical Association . In that study, Bhasin and his colleagues analyzed 44 SARM products they bought online, and found that only about half actually contained the drugs. On the other hand, 39% contained other unapproved drugs, such as steroids or growth hormones. Auchus said it's best to avoid any online product purporting to be a muscle-builder. Even if the ingredients are accurately listed on the label, he said, a consumer would have a hard time knowing whether a product contains SARMs (or other unapproved substances): They go by names like ostarine, andarine and testolone. Bhasin pointed to another risk of SARM use: It can lead to abuse of other substances, ranging from steroids for more muscle-building to "benzos" to deal with the side effect of sleep disturbances. So the issue, for many SARM users, is one of mental health and dependence on substances, according to Bhasin. Simply telling them to stop, he said, is akin to telling someone with anorexia to "just eat." "In the press, this is often portrayed as an issue of cheating in sports," Bhasin said. "But this is really a public health challenge." Sources Richard Auchus, MD, PhD, professor, internal medicine, University of Michigan Medical School, chief, endocrinology and metabolism section, Ann Arbor VA Medical Center, Ann Arbor Shalender Bhasin, MD, director, Research Program in Men’s Health: Aging and Metabolism, Brigham and Women's Hospital, professor, medicine, Harvard Medical School, Boston U.S. Food and Drug Administration, news release, April 26, 2023 Posted May 2023