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February 10, 2015

Testosterone Replacement Therapy Faces FDA Scrutiny

Author Affiliations
  • 1Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, Massachusetts

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

JAMA. 2015;313(6):563-564. doi:10.1001/jama.2014.17334

The use and the potential for cardiovascular risk associated with testosterone replacement therapy (TRT) were examined in September 2014 by a joint US Food and Drug Administration (FDA) advisory committee.1 Prompted by several studies suggesting cardiovascular risk associated with TRT,2,3 the advisory committee discussed whether TRT for age-related hypogonadism (a decline in testosterone levels as a consequence of aging, and for which the majority of testosterone usage is directed to today) is supported by data, evaluated the cardiovascular risks, and determined whether additional studies were warranted to examine the appropriateness of TRT usage in light of these risks.