The Food and Drug Administration (FDA) announced that prescription testosterone product labels must be changed to clarify the approved use of these medications and information on the possible increased risk of heart attacks and strokes in patients taking testosterone must also be added.

Testosterone is an FDA-approved replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause hypogonadism. The FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no reasons other than aging. The safety and efficacy of this use of testosterone has not been established.

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After reviewing evidence from published research and expert input from an Advisory Committee meeting, the FDA has concluded that there is a potential increased cardiovascular risk linked with testosterone use; some studies indicated an increased risk of heart attack, stroke, or death associated with testosterone treatment, although others did not. All prescription testosterone products must now update their labels to include information on the possible increased risk of heart attacks and strokes. Manufacturers of approved testosterone products must also conduct a well-designed clinical trial to further examine this risk.


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