Monday, 29 April, 2024
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Muscle bulking supplement warning from FDA

The US Food and Drug Administration (FDA) says it continues to receive adverse event reports linked to selective androgen receptor modulators – or supplements – commonly called SARMs, marketed as a quick way to gain muscle mass or increase athletic performance.

Social media posts by influencers and sellers of SARMs contribute to the availability and promotion of these dangerous products, said the agency, mainly targeting teenagers and young adults through videos on various platforms.

SARMs, which are chemical substances that mimic the effects of testosterone and anabolic steroids, are not FDA approved, yet online vendors and social media influencers reassure consumers that they are safe and effective.

The reality is SARMs are potentially dangerous. The FDA said the actual number of people having bad reactions is probably even higher, due to under-reporting.

“Because these are not approved drugs, consumers may be reluctant to report adverse events or may not be aware that they can report any negative effects. In addition, they might not know that their symptoms are being caused by the product,” said the agency.

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

  • Increased risk of heart attack or stroke
  • Psychosis/hallucinations
  • Sleep disturbances
  • Sexual dysfunction
  • Liver injury and acute liver failure
  • Infertility
  • Pregnancy miscarriage
  • Testicular shrinkage

Although often marketed as dietary supplements or “sold for research use only”, they are considered unapproved drugs, and are often sold with no warnings on the labels, potentially leading consumers to believe they are safe.

The FDA said over the years, it had issued warning letters to companies selling unapproved products marketed as SARMs, and and had also pursued criminal actions for distributors of the products.

"We are extremely concerned about unscrupulous companies marketing body-building products with potentially dangerous ingredients. They have been associated with serious safety concerns, including potential to increase the risk of heart attack or stroke and life threatening reactions like liver damage,” said Donald Ashley, director of the Office of Compliance in the FDA’s Centre for Drug Evaluation and Research.

“We will continue to take action against companies marketing these products.”

 

US FDA notice (Open access)

 

See more from MedicalBrief archives:


 

Increase in liver injury linked to herbal and dietary supplements — Australian study

 

Testosterone supplements

 

SA pharmacies ‘knowingly stock dangerous and ineffective products’

 

Body-building protein supplement has potential for brain harm

 

 

 

 

 

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