Certain bodybuilding products put consumers at risk for heart attack, stroke, serious liver damage and more

FDA continues to warn consumers about bodybuilding products labeled to contain steroid and steroid-like substances.

These bodybuilding products often contain selective androgen receptor modulators, commonly called SARMs, and have not been approved by the FDA. SARMs are chemical substances that mimic the effects of testosterone and anabolic steroids. These products are illegally marketed and are often promoted to increase muscle mass and strength.

Although the products are generally marketed as dietary supplements, they are not dietary supplements. Instead, these products are unapproved drugs that FDA has not reviewed for safety and effectiveness.

SARMs cause harm

Life-threatening reactions, including liver injuries that required hospitalization, have occurred in people taking products containing SARMs. SARMs also have the potential to cause:

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

Information for consumers

• Don’t be fooled by social media posts that target teenagers and young adults and tout SARMs as a quick or easy way to improve physical appearance, gain muscle mass or increase athletic performance.
• These products are often sold with no warnings on the labels, potentially leading consumers to believe the products are safe.
• These products also are sometimes “for research purposes” or “not for human consumption.” These products have been sold directly to consumers for human use with dosing instructions. The agency urges consumers not to purchase these products which are of unknown quality and may be harmful to your health.
• Consumers should consult their health care professional if they are experiencing symptoms that have been associated with these products, particularly nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, jaundice (yellowing of the skin or whites of the eyes) or brown/discolored urine.
• FDA also recommends consumers talk to a health care professional about the use of any products for increasing muscle mass or enhancing athletic performance.

Information for health care professionals

• Health care professionals should be on alert for patients with the warning signs associated with the use of steroids or steroid-like substances including liver injury, kidney injury, stroke and hormone-associated adverse effects including pulmonary embolism and deep vein thrombosis.

Report adverse events to FDA

Health care professionals and consumers should report any adverse events related to the use of these bodybuilding products to the FDA’s 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.

FDA Actions

An FDA laboratory recently tested GE Labs Ykarine. The testing found the product contained undeclared trendione (estra-4,9,11-triene-3,17-dione), which is an anabolic steroid and is classified as a schedule III-controlled substance by the U.S. Drug Enforcement Administration. Anabolic steroids can cause serious liver injury and life-threatening reactions such as heart attack, stroke, pulmonary embolism, deep vein thrombosis and kidney damage.

The laboratory analysis also confirmed the product contains YK-11, which is a listed ingredient on the product label. The agency testing was based on an adverse event report of a consumer who used the product and subsequently suffered a stroke.

The agency urges consumers not to use GE Labs Ykarine. Consumers who have this product should discard it.