In February 2025, the labeling requirements for testosterone caught up with what urologists and other prescribers have known for years: testosterone does not increase the risk of adverse cardiovascular outcomes.1
The journey to this conclusion began in 2014, when the FDA first convened a Joint Meeting of the Bone, Reproductive and Urologic Drugs and the Drug Safety and Risk Management Advisory Committee to discuss increased reports of stroke, heart attack, and death in men who were taking testosterone. The result of these discussions was to initiate a trial to assess the safety of testosterone in men with hypogonadism—a trial we now know as the TRAVERSE trial (NCT03518034).
The results from TRAVERSE were reassuring. Published in 2023 in the New England Journal of Medicine, the data showed that the incidence of major…