FDA investigates testosterone product safety

February 24, 2014

Healthcare professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment.

The Food and Drug Administration (FDA) said it is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.

In a Jan. 31 safety announcement, the agency said: “Healthcare professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment… We urge healthcare professionals and patients to report side effects involving prescription testosterone products to the FDA MedWatch program.”

The investigation was prompted by the publication of two recent studies, published online in PLOS ONE and in the Journal of the American Medical Association (JAMA),  that found increased risk of heart attack and stroke in men who take testosterone products.

“These findings raise concerns about the potential safety of testosterone therapy,” wrote the authors of the JAMA study.

The agency said it “has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death” and that patients should speak with their physicians before discontinuing any treatment programs.