Citing a sharp increase in the number of men using testosterone drugs in recent years, FDA recently convened a joint advisory committee meeting on testosterone replacement therapy ("TRT"). The committee focused on the appropriate patient population for TRT and the potential risk for major adverse cardiovascular events, such as stroke or heart attack, associated with TRT. The Advisory Committee voted 20–1 for FDA to impose new labeling requirements, including providing additional risk information and to restrict TRT to those with low testosterone due to medical conditions, which would prevent the marketing of TRT for age-related testosterone issues. The committee also recommended further studies to assess the risks associated with long-term use of TRT. FDA is not required to follow advisory committee recommendations but often does so.
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