FDA Explores Testosterone Therapy Labeling Revisions

The FDA is actively exploring potential revisions to the labeling of testosterone replacement therapy. This initiative comes shortly after the agency removed black box warning labels from estrogen therapy products used in menopause.

During an expert panel discussion, FDA Commissioner Martin Makary highlighted the parallels between estrogen and testosterone therapies, noting that outdated beliefs about their safety may hinder patient care.

Nine experts, including academics and clinicians, emphasized the need for updated research and better understanding of testosterone's role in male health, advocating for changes in labeling and substance control, according to STAT News.