FDA Warns of Use of Selective Androgen Receptor Modulators … – FDA.gov

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The U.S. Food and Drug Administration is warning consumers that the agency continues to receive adverse event reports related to selective androgen receptor modulators, commonly called SARMs. Social media posts by influencers and sellers of SARMs contribute to the availability and promotion of these dangerous products.

Targeting teenagers and young adults, videos on social media platforms tout SARMs as a quick or easy way to improve physical appearance, gain muscle mass, or increase athletic performance.

SARMs, which are chemical substances that mimic the effects of testosterone and anabolic steroids, are not FDA approved. Online vendors and social media influencers are using social media to make SARMs seem safe and effective.

The reality is SARMs are potentially dangerous. The FDA continues to receive adverse event reports associated with SARMS use. The real number of consumers experiencing adverse events is likely higher due to underreporting. Because these are not approved drugs, consumers may be reluctant to report adverse events or may not be aware that they can report adverse events that they experience. In addition, they might not know that their symptoms are being caused by the product.

Studies and reports show SARMs are associated with serious or life-threatening health problems, such as:

Although SARMs are often marketed as dietary supplements or sold for research use only, they are considered unapproved drugs. SARMs cannot be legally marketed in the U.S. as a dietary supplement or drug at this time. These products are often sold with no warnings on the labels, potentially leading consumers to believe the products are safe.

The FDA recommends consumers talk to a health care professional about the use of any products for increasing muscle mass or enhancing athletic performance.

The FDA has issued warning letters to companies selling unapproved products marketed as SARMs over the years. The FDA has also pursued criminal actions for distributors of these products.

Because these are unapproved drug products with potentially dangerous side effects, and they have not been reviewed by the FDA for safety or efficacy, consumers should be advised against using SARMs. Consumers should consult a health care professional if they are experiencing any side effect they believe may be associated with the use of a SARMs product.

The FDA encourages health care professionals and consumers to report any adverse event related to the use of SARMs products to the FDAs MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178.

Additional guidance on how to report issues with products can be found at the FDA 101: How to Use the Consumer Complaint System and MedWatch.

Additionally, you can reach out to your local consumer complaint coordinator: Consumer Complaint Coordinators.

04/26/2023

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FDA Warns of Use of Selective Androgen Receptor Modulators ... - FDA.gov