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News From the Food and Drug Administration
April 7, 2015

Testosterone Medications Need New Label Information

Author Affiliations

Copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2015;313(13):1306. doi:10.1001/jama.2015.2192

Men should not use prescription testosterone products to counteract the effects of aging, the US Food and Drug Administration (FDA) said March 3 in a safety announcement. In addition, the agency concluded that testosterone use might be linked to an increased cardiovascular risk (http://1.usa.gov/18idNd4).

“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 agency noted. “Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.” Such medical conditions include damage from chemotherapy or infection and disorders of the testicles, pituitary gland, or brain.