The FDA has issued warning letters on SARMs in dietary supplements. FDA has cautioned products containing Selective Androgen Receptor Modulators (SARMs) are unapproved drugs the agency has not reviewed for safety and effectiveness. Recent warning letters show FDA is targeting companies selling Ostarine and other SARMs in products marketed as dietary supplements.
“We are extremely concerned about unscrupulous companies marketing body-building products with potentially dangerous ingredients” said the Director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. According to the FDA, consumers who have taken products containing SARMs have suffered-life threatening reactions, including liver toxicity. SARMs could also increase the risk of heart attack and stroke. Aside from that, their long-term effects on the body are unknown.
“Body-building products that contain SARMs have not been approved by the FDA and are associated with serious safety concerns, including potential to increase the risk of heart attack or stroke and life threatening reactions like liver damage,” the Director said. “We will continue to take action against companies marketing these products to protect the public health.”
Consumers should stop using these body-building products immediately and consult a health care professional if they are experiencing any adverse reactions that may be associated with their use. Health care professionals and consumers should also report any adverse events related to the use of these body-building products to the FDA’s MedWatch Adverse Event Reporting program.
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