Overview
- The Department of Health and Human Services and the FDA announced on Thursday that they have changed testosterone replacement therapy product labeling to remove broad safety and efficacy cautions tied to age-related low testosterone.
- The agencies cited a landmark 2023 randomized trial of more than 5,200 men that found no meaningful increase in major adverse cardiovascular events for men on testosterone therapy compared with placebo.
- The updated labels continue to bar use in men with metastatic or advanced prostate cancer and ask clinicians to screen and monitor patients for prostate issues and severe benign prostatic hyperplasia.
- HHS officials including Assistant Secretary Brian Christine and Secretary Robert F. Kennedy Jr. framed the relabeling as evidence-based and aimed at expanding informed access while stressing that testosterone has known side effects and requires medical supervision.
- The change could increase prescribing and fuel policy moves on men’s health such as a proposed Office of Men’s Health, but some clinicians remain cautious and point to unresolved risks reported in trials such as higher rates of atrial fibrillation and blood clots.