It may soon get easier for older men to get ahold of testosterone therapy.
On Thursday, the Department of Health and Human Services (HHS) announced that it is requesting updates to the prescribing information testosterone replacement therapy drugs, or TRT.
The department is hoping to roll back restrictions on access for older men — but not all experts are convinced there’s enough research to make such sweeping changes.
In 2015, the FDA slapped warning labels on testosterone medications, cautioning that they weren’t proven safe for low-T and might trigger heart attacks or strokes.
Now, HHS is reversing course. Citing new research that suggests the hormone is far less risky than once feared, officials dropped the cardiovascular warnings in 2025 and are now pushing to tone down alerts regarding prostate cancer and enlargement.
“During Men’s Health Month, we are putting science back at the center of men’s healthcare,” HHS Secretary Robert F. Kennedy Jr. declared 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 requires a prescription and is used to treat hypogonadism, when the testicles don’t produce enough sex hormones — mainly testosterone. It can help improve sex drive, boost performance, increase muscle, drop fat, and stabilize energy and mood.
Research suggests testosterone levels naturally start decreasing around age 35. Around 35% of men older than 45 have hypogonadism.
Excess body fat also lowers testosterone levels, and low testosterone makes it harder to lose weight. As many as 30-50% of men with obesity or type 2 diabetes have hypogonadism.
The 2015 warnings were prompted by potential heart risks — and, HHS said this week, “limited” evidence of benefits.
But the department said more recent research suggests heart risk may not be as big of a problem as feared, citing the 2023 TRAVERSE trial, which examined over 5,200 men with high risks of heart disease and symptoms of hypogonadism.
Researchers found that testosterone caused about the same number of major cardiac events — like heart attacks, strokes and death — as a placebo.
However, compared to the placebo group, those using TRT were more likely to have developed atrial fibrillation, an irregular heart rate that can increase the risk for stroke and heart failure, and pulmonary embolism, a blood clot blocks blood flow to a lung artery.
“The cardiovascular effects of testosterone-replacement therapy in middle-aged and older men with hypogonadism have not been determined,” the authors concluded.
While some experts say testosterone is safe, others insist more research is needed.
But based on this study and “other available evidence” that the HHS doesn’t cite, the “FDA has concluded that the limitation of use is no longer warranted.”
“As our understanding of testosterone therapy continues to evolve, prescribing information should reflect the best available science,” said Brian J. Christine, M.D., Assistant Secretary for Health. “This action helps ensure patients and healthcare providers have accurate, up-to-date information when considering treatment options.”
Currently, labels on testosterone warn that men with prostate cancer, or even suspected prostate cancer, should not use it. Research shows that cancer can grow and multiply with TRT.
It also says it could increase the risk for developing prostate cancer.
The HHS is suggesting use only be limited for people with metastatic prostate cancer, or prostate cancer that spread to other parts of the body. Experts say that TRT does not increase the risk of developing prostate cancer in people who do not have it already.
“However, important uncertainties remain because prostate cancer can take years to develop,” the HHS said. “The proposed labeling continues to recommend that healthcare providers assess risk, screen patients before treatment and monitor patients during therapy.”
The FDA is also requesting updates to labeling information related to benign prostatic hyperplasia, or a noncancerous enlargement of the prostate.
Currently, the labels say TRT could make it worse. The FDA is asking to change labels to recommend “continued monitoring of patients with severe symptomatic disease during treatment.”
The FDA found that TRT doesn’t make symptoms worse for men with mild to moderate benign prostatic hyperplasia, but the TRT’s effects are more unclear for men with severe symptoms.
“FDA’s responsibility is to ensure prescribing information reflects the best available scientific evidence,” said Michael Davis, M.D., Ph.D., acting director of FDA’s Center for Drug Evaluation and Research. “These updates provide patients and healthcare professionals with clearer information about the benefits and risks of testosterone replacement therapy and support informed treatment decisions.”
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