The US Department of Health and Human Services is asking for revisions to the labels on testosterone replacement therapies for men after reviewing new data and evidence on their safety and benefits, a move that would loosen long-standing warnings written by federal regulators. The requested changes would remove a statement that the safety and effectiveness of testosterone replacement therapy have not been established in men with age-related low testosterone, while also updating information on prostate cancer risk and warnings about enlarged prostate.
Who Decides What Men Are Told
HHS announced the request Thursday, putting the federal health apparatus back in the business of redrawing the boundaries around a treatment that has been treated with caution for years. The agency said the label revisions would reflect current evidence. HHS Secretary Robert F. Kennedy Jr. said in the announcement, "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."
That official language sits atop a system where federal agencies decide what warnings appear on medicine labels, and where those warnings can shape what doctors prescribe, what insurers cover, and what patients are told to fear or trust. Dr. Jamin Brahmbhatt, a urologist and men’s health expert at Orlando Health in Florida, said the government has only requested updates to testosterone therapy product labels, and no changes have been officially made yet. Brahmbhatt said, "And taking a warning off a label isn’t the same as saying every man should be on it."
He added, "Testosterone is still a medical therapy, not a wellness drug. This new proposal should not make it the wild wild west for prescribers and patients – there still need to be guardrails in place, like for any medical therapy. I’m also hopeful clearer labels help more insurers cover it for the men who truly need it."
Who Pays for the Rules at the Top
The people most affected are ordinary men navigating a treatment that has been surrounded by warnings about heart problems, prostate cancer and accelerated prostate growth. HHS said the 2015 label changes required by the US Food and Drug Administration stated that the safety and effectiveness had not been established for men who had signs and symptoms associated with idiopathic hypogonadism, a condition that involves low testosterone levels. That limitation was added because, according to HHS, "evidence of benefit was limited and concerns had been raised about possible cardiovascular risks."
Now HHS says additional research has emerged, including a large clinical study involving more than 5,200 men that found no "meaningful increase" in major cardiovascular events, such as heart attack or stroke, among people receiving testosterone therapy. The agency also said current labels generally advise against testosterone therapy in men who have known or suspected prostate cancer and caution that treatment may increase the risk of developing the disease, but more recent research data "have not generally shown an increased risk of prostate cancer in men receiving testosterone replacement therapy."
Under the requested revisions, the therapy would be advised against only in men whose prostate cancer has spread. For enlarged prostate, HHS said current labels generally warn that testosterone therapy may worsen symptoms of benign enlarged prostate, but a new FDA review found no evidence of that happening in men with mild to moderate versions of the condition. For men with more severe symptoms, HHS said evidence remains limited and "the labeling changes requested would recommend continued monitoring of patients with severe symptomatic disease during treatment."
What They Call Evidence
Dr. Eddie Hackler III, an Atlanta-based cardiologist and author of the book Follow Your Heart, said the new HHS request to change the language on labels "removes the fear" around testosterone replacement therapy. Hackler said, "Testosterone therapy has proven benefits for specific symptoms; particularly improved libido, sexual function, correction of anemia, and modest improvements in mood and energy. Proper diagnosis is essential before starting therapy."
He also said, "Testosterone therapy does not appear to increase the risk of heart attacks, strokes, or prostate cancer based on the best available randomized trial data." Hackler added that potential risks and side effects may include skin reactions, acne, enlargement of male breast tissue, pulmonary embolism or blood clots, irregular heart rhythms, suppression of sperm production and minimal increase in blood pressure.
The new move by HHS is the latest in the Trump administration’s efforts to reduce restrictions on hormone therapies. Last year, the administration took similar steps on hormone therapy for women when the FDA removed black box warnings from menopausal hormone therapy products. In December, the FDA hosted an expert panel discussion on testosterone replacement therapy for men. Since then, the agency has been looking into potential new treatment options involving testosterone therapy for men.
Dr. Adam Baumgarten, associate professor in the University of Alabama at Birmingham Department of Urology, said the new HHS request to change the warning labels on testosterone therapy have been "a long time coming." Baumgarten said, "The first major takeaway is that the cardiovascular safety concerns that have surrounded testosterone therapy for the past decade are no longer supported by randomized trial data."
He said, "Second, the FDA has meaningfully narrowed its prostate cancer warning. Rather than a broad caution against use in men with a history of prostate cancer, the focus is now more specifically on metastatic disease." He added, "Third, this is not a signal for indiscriminate use. Testosterone therapy still requires a clear diagnosis based on both symptoms and consistently low testosterone levels, and men on therapy require ongoing monitoring with appropriate laboratory follow-up."
Healthcare providers generally consider testosterone levels below 300 nanograms per deciliter of blood as low in adults. Baumgarten said normal testosterone levels vary with age and are not defined by a single fixed value for all men. Brahmbhatt said normal testosterone levels in men can range widely, from around 300 to more than 800 nanograms per deciliter, depending on which guidelines are followed or which lab tests were conducted.
Brahmbhatt said that when prescribing testosterone, he looks for "a level that’s genuinely low, confirmed on two separate morning blood draws when testosterone naturally peaks," and he makes sure it aligns with symptoms, such as low sex drive, fatigue, trouble with erections or loss of muscle. Brahmbhatt said, "For a man who is genuinely low, the benefits are real: improved energy, sex drive, mood, muscle, and bone strength."
He also said, "For a man whose levels are already in a normal range and who’s just chasing an improvement in health motivated by online influencers, the risks may not outweigh the benefits." Brahmbhatt added, "I don’t want anyone overpromising here. Testosterone can suppress a man’s own sperm production, it can thicken the blood, and the long-term prostate picture still isn’t fully clear."