FDA Wants Stroke, Heart Attack Warning Added to Testosterone Labels

The FDA has issued a warning about testosterone products and is now mandating that all manufacturers include labeling that both clarifies approved uses of the treatment as well as the possibility of an increased risk of heart attack and stroke.

The agency has also stressed that prescription testosterone is only meant to be used by men who have low testosterone due to specific medical conditions, not for treatment of low testosterone due to older age.

The agency decided to add a warning for increased risk of heart attack and stroke after an FDA Advisory Committee concluded that there was possibility of an increased risk of cardiovascular events while using testosterone. The recommendation was based off expert input and several studies, some of which focused on aging men treated with testosterone.

Currently, testosterone replacement therapy is only approved for men with disorders of the testicles, pituitary gland, or brain, which can cause hypogonadism.

In addition to updates to product labels, the FDA is requiring manufacturers to conduct a clinical trial — together or separately, if they wish — to address and better define the increased risk for cardiovascular events among testosterone users.

The FDA urges health care professionals to only prescribe testosterone to men with certain medical conditions that have been confirmed by laboratory tests. They should make patients aware of the possibility of an increased risk of heart attack and stroke, and patients on testosterone that experience symptoms related to one of these cardiovascular events should seek medical attention immediately. 

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