Please call (212) 203-7710 for an initial consultation and case evaluation.

FDA Safety Communications

FDA Drug Safety Communications

Major Testosterone Therapy Studies

A November 2013 study of older men in the U.S. Veteran Affairs health system published in the Journal of the American Medical Association revealed a potential 30% increased risk of stroke, heart attack, and death in a test group that had been prescribed testosterone therapy.

A second study in January 2014 reported a doubling of the risk of heart attack among both men aged 65 years and older and men aged less than 65 years old with a pre-existing history of heart disease, within 90 days following their first testosterone therapy prescription.

FDA Drug Safety Communications

On January 31, 2014, based upon the above studies, the U.S. Food & Drug Administration (FDA) announced it would be investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone therapy products.

On June 19, 2014, given reports of venous blood clots, the FDA required testosterone therapy product manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins (venous thromboembolism), including deep vein thrombosis and pulmonary embolism.

On March 3, 2015, the FDA issued a drug safety communication which, among other directives:

  • Concluded that there was a possible increased cardiovascular risk associated with testosterone use
  • Cautioned that prescription testosterone products were approved only for men suffering hypogonadism as confirmed by laboratory testing, and that the benefit and safety of testosterone products were not established for the treatment of low testosterone levels due to aging
  • Required manufacturers of all approved prescription testosterone products to change their labeling to clarify the approved uses of testosterone therapy products and add information about a possible increased risk of heart attacks and strokes associated with testosterone use
  • Required manufacturers of approved testosterone products to conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of testosterone products.

If you or a family member have taken testosterone therapy replacement drugs, medications or treatments (with or without experiencing side effects or related conditions), you and/or your family member may be entitled to money damages.

Please call (212) 203-7710 or visit us here for an initial consultation and case evaluation.