It might soon become easier for older men to access testosterone therapy.
On Thursday, the Department of Health and Human Services (HHS) announced its intention to revise the prescribing information for testosterone replacement therapy (TRT) drugs.
The goal is to relax some of the restrictions on access for older men. However, not everyone is convinced that the current research justifies such broad changes.
In 2015, the FDA added warning labels to testosterone medications, stating that they hadn’t proven safe for low testosterone levels and could potentially lead to heart attacks or strokes.
Now, HHS appears to be reversing its stance. With new studies suggesting that the hormone may be less risky than previously believed, officials removed cardiovascular warnings in 2025 and are now looking to ease concerns related to 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. stated 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.”
What is TRT taken for?
TRT requires a prescription and is used to treat hypogonadism, which occurs when the testicles don’t produce enough testosterone. The therapy can help improve sexual drive, enhance performance, increase muscle mass, reduce fat, and stabilize energy and mood.
Research indicates that testosterone levels naturally begin to decline around age 35. About 35% of men older than 45 exhibit signs of hypogonadism.
Additionally, excess body fat can further lower testosterone levels, and low testosterone can make weight loss more challenging. It’s estimated that 30-50% of men with obesity or type 2 diabetes have hypogonadism.
TRT and the heart
The warnings from 2015 were based on concerns about heart risks, with the HHS noting recently that there was “limited” evidence of the benefits.
However, the department indicated that newer research suggests that the risk to heart health might not be as significant as once thought, referring to the 2023 TRAVERSE trial, which studied over 5,200 men who were at high risk for heart disease and exhibited symptoms of hypogonadism.
Results showed that testosterone created a similar incidence of major cardiac events—like heart attacks, strokes, and death—as a placebo.
Yet, those on TRT were more likely than those on a placebo to experience atrial fibrillation (an irregular heartbeat that can heighten the risk of stroke and heart failure) and pulmonary embolism (a blood clot that restricts 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 researchers concluded.
While some experts argue testosterone is safe, others call for further investigation.
Nevertheless, the FDA has determined that limiting the use of testosterone is no longer necessary based on this study and “other available evidence” that the HHS did not cite.
“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 ensures that patients and healthcare providers have accurate, up-to-date information when considering treatment options.”
TRT and prostate health
Currently, testosterone labels indicate that men with prostate cancer, or even those suspected of having it, should not use the therapy. Research indicates that cancer can grow and proliferate with TRT.
The labels also suggest a potential increased risk of developing prostate cancer.
The HHS is proposing that restrictions apply only to those with metastatic prostate cancer—cancer that has spread to other areas of the body. Experts assert that TRT does not elevate the risk of developing prostate cancer in individuals who do not already have it.
“However, significant uncertainties remain, as prostate cancer can take years to develop,” the HHS stated. “The proposed labeling continues to recommend that healthcare providers assess risk, screen patients before treatment, and monitor patients during therapy.”
The FDA is also asking for updates to the labeling concerning benign prostatic hyperplasia, a non-cancerous enlargement of the prostate.
At present, labels indicate TRT could worsen this condition. The FDA is recommending changes to suggest “continued monitoring of patients with severe symptomatic disease during treatment.”
The FDA found that TRT does not exacerbate symptoms for men with mild to moderate benign prostatic hyperplasia, yet the effects remain unclear for those with severe symptoms.
“FDA’s responsibility is to ensure that prescribing information reflects the best available scientific evidence,” stated 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 insights about the benefits and risks of testosterone replacement therapy and support informed treatment decisions.”
