The Trump administration is moving to roll back longstanding restrictions on testosterone replacement therapy, in a decision that has divided medical experts over whether the evidence justifies easing warnings that have governed the drug’s use for nearly a decade.
The Department of Health and Human Services announced on Thursday that it is requesting updates to the prescribing information for testosterone replacement therapy, commonly known as TRT, with the aim of making the treatment more accessible to older men. The move builds on a decision made in 2025 to drop cardiovascular warning labels that had been attached to testosterone medications since 2015, when the FDA first cautioned that the drugs were not proven safe for low testosterone and might trigger heart attacks or strokes.
HHS Secretary Robert F. Kennedy Jr. framed the change as a return to evidence-based policy. “During Men’s Health Month, we are putting science back at the center of men’s healthcare,” he said in a press release. “By updating testosterone therapy labels to reflect current evidence, we are giving patients and physicians clearer information, supporting informed medical decisions, and improving care for millions of American men.”
TRT is prescribed to treat hypogonadism, a condition in which the testicles fail to produce sufficient levels of testosterone, and is used to improve sex drive, sexual performance, muscle mass, fat loss and mood stability. The condition becomes increasingly common with age, with testosterone levels naturally beginning to decline around age 35, and an estimated 35 per cent of men over 45 affected by hypogonadism. Excess body fat further lowers testosterone levels, with as many as 30 to 50 per cent of men with obesity or type 2 diabetes affected by the condition.
The cardiovascular warnings introduced in 2015 stemmed from concerns about heart risk combined with what HHS now describes as “limited” evidence of benefit at the time. The department points to the 2023 TRAVERSE trial, which examined more than 5,200 men with elevated cardiovascular risk and symptoms of hypogonadism, as supporting evidence for relaxing the restrictions. The trial found that testosterone caused roughly the same number of major cardiac events, including heart attacks, strokes and death, as a placebo. However, those taking TRT were more likely to develop atrial fibrillation, an irregular heart rhythm linked to increased stroke and heart failure risk, as well as pulmonary embolism, a potentially serious blood clot affecting the lungs. The study’s authors concluded: “The cardiovascular effects of testosterone-replacement therapy in middle-aged and older men with hypogonadism have not been determined.”
Assistant Secretary for Health Brian J. Christine defended the decision to proceed despite that uncertainty. “As our understanding of testosterone therapy continues to evolve, prescribing information should reflect the best available science,” he said. “This action helps ensure patients and healthcare providers have accurate, up-to-date information when considering treatment options.”
Changes are also proposed to warnings concerning prostate health. Current labelling advises that men with prostate cancer, or even suspected prostate cancer, should avoid testosterone therapy, given evidence that the hormone can accelerate tumour growth. Under the proposed changes, that restriction would be narrowed to apply only to men with metastatic prostate cancer, which has spread to other parts of the body. Experts note that TRT does not appear to increase the risk of developing prostate cancer in men who do not already have it, though HHS acknowledged that “important uncertainties remain because prostate cancer can take years to develop,” and said the proposed labelling would continue to recommend that healthcare providers assess risk, screen patients before treatment and monitor them throughout therapy.
A further proposed change relates to benign prostatic hyperplasia, a noncancerous enlargement of the prostate. Current labelling warns that TRT could worsen the condition, but FDA review found no evidence of worsening symptoms in men with mild to moderate cases, with effects remaining less clear for those with more severe symptoms. The updated labelling would recommend “continued monitoring of patients with severe symptomatic disease during treatment.”
Michael Davis, acting director of the FDA’s Center for Drug Evaluation and Research, said the agency’s responsibility was to ensure labelling reflected the most current scientific understanding. “FDA’s responsibility is to ensure prescribing information reflects the best available scientific evidence,” he said. “These updates provide patients and healthcare professionals with clearer information about the benefits and risks of testosterone replacement therapy and support informed treatment decisions.”
