What men should know about the US government’s latest move on testosterone therapy

By Jacqueline Howard, CNN

(CNN) — The US Department of Health and Human Services is requesting revisions to the labels on testosterone replacement therapies for men after reviewing new data and evidence on their safety and benefits. These updates could pave the way for easier access to testosterone replacement therapy.

The requested label changes would include removing a statement that the safety and effectiveness of testosterone replacement therapy have not been established in men with age-related low testosterone, HHS announced Thursday.

The agency also calls for updating information related to prostate cancer risk and revising warnings regarding enlarged prostate.

“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,” HHS Secretary Robert F. Kennedy Jr. said in the announcement.

Experts warn that patients should still have in-depth talks with their doctors about whether testosterone therapy could be helpful for them, and doctors should complete thorough evaluations.

Although the HHS announcement reflects “science finally catching up to reality,” the government has only requested updates to testosterone therapy product labels, and no changes have been officially made yet, noted Dr. Jamin Brahmbhatt, urologist and men’s health expert at Orlando Health in Florida.

“And taking a warning off a label isn’t the same as saying every man should be on it,” Brahmbhatt said in an email.

“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,” he said. “I’m also hopeful clearer labels help more insurers cover it for the men who truly need it.”

A new look at the safety

Some of the concerns about testosterone therapy’s potential risks included heart problems, prostate cancer and accelerated prostate growth. These concerns have shaped how the therapies have been labeled and prescribed.

Heart risks

In 2015, the US Food and Drug Administration required label changes on testosterone therapy that stated 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 to labels because “evidence of benefit was limited and concerns had been raised about possible cardiovascular risks,” according to HHS.

But additional research has since 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, HHS said.

Cancer concerns

HHS also pointed to how the scientific picture has evolved around prostate cancer risks and testosterone therapy.

Current labels on testosterone therapy generally advise against its use in men who have known or suspected prostate cancer, and they caution that treatment may increase the risk of developing the disease, HHS said.

But more recent research data “have not generally shown an increased risk of prostate cancer in men receiving testosterone replacement therapy,” the agency said, and under the requested revisions, the therapy would be advised against only in men whose prostate cancer has spread.

Enlarged prostate

Similarly, current labels on therapies generally warn that testosterone therapy may worsen symptoms of benign enlarged prostate. But HHS said that a new FDA review found no evidence of that happening in men with mild to moderate versions of the condition.

However, 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.”

The new HHS request to change the language on labels “removes the fear” around testosterone replacement therapy, Dr. Eddie Hackler III, an Atlanta-based cardiologist and author of the book “Follow Your Heart,” said in an email.

“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 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 said. He 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.

‘A long time coming’

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.

The new HHS request to change the warning labels on testosterone therapy have been “a long time coming,” Dr. Adam Baumgarten, associate professor in the University of Alabama at Birmingham Department of Urology, said in an email.

“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,” Baumgarten 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 said. “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.”

What’s considered low?

Healthcare providers generally consider testosterone levels below 300 nanograms per deciliter of blood as low in adults.

“At the same time, it is widely recognized that normal testosterone levels vary with age and are not defined by a single fixed value for all men,” Baumgarten said.

What are considered normal testosterone levels in men can range widely, from around 300 to more than 800 nanograms per deciliter, but even that depends on which guidelines are followed or which lab tests were conducted, Brahmbhatt said.

When prescribing testosterone, Brahmbhatt said, 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.

“For a man who is genuinely low, the benefits are real: improved energy, sex drive, mood, muscle, and bone strength,” Brahmbhatt said of testosterone therapy.

“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,” he said. “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.”

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