FDA Update on Testosterone Replacement Therapy

Categories: Spring 2015

In March, the U.S. Food and Drug Administration (FDA) determined that prescription testosterone therapy is approved only for men who have low testosterone levels caused by certain medical conditions, not men with agerelated low testosterone. “The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone,” the FDA said in a statement. “Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.”

Testosterone replacement therapy is approved by the FDA for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause a condition called hypogonadism. Examples of these disorders include failure of the testicles to produce testosterone due to genetic problems, or damage from chemotherapy or infection.

The FDA also concluded that there is a possible increased cardiovascular risk associated with testosterone use based on available evidence. Some studies reported an increased risk of heart attack, stroke, or death in men treated with testosterone, although other studies did not report a link. The agency will require labeling changes for all prescription testosterone products to reflect the possible increased risk of cardiovascular events.

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