FDA Drug Safety Podcast: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use

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Welcome to FDA Drug Safety Podcasts for healthcare professionals from the Division of Drug Information.

On March 3, 2015 FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. 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. We are requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. We are also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. 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 is FDA-approved as replacement therapy only for men with low testosterone levels due to disorders of the testicles, pituitary gland, or brain that can cause hypogonadism. However, FDA has become aware of testosterone being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.

Additionally, based on the available evidence from published studies and expert input from an advisory committee, FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use. These studies included aging men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not.

We are requiring labeling changes for all prescription testosterone products to reflect the possible increased cardiovascular risk associated with testosterone use. We are also requiring manufacturers of approved testosterone products to conduct a well-designed clinical trial to more clearly address the question of whether an increased cardiovascular risk exists among users of these products. Health care professionals should make patients aware of this possible risk when deciding on testosterone therapy. Side effects involving testosterone products should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.

Thank you for listening. A link to the full communication detailing specific information for healthcare professionals, a list of FDA-approved testosterone products, and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications.

If you have drug questions, you can reach us at druginfo@fda.hhs.gov. And follow us on Twitter @FDA_Drug_Infodisclaimer icon for up to the minute important drug information. Know the moment it happens.

Page Last Updated: 03/05/2015
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