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

- The US Department of Health and Human Services is requesting changes to testosterone therapy labels after reviewing new safety data.

- Recent studies involving thousands of men found no meaningful increase in heart attacks or strokes among those receiving testosterone therapy.

- Experts emphasize that testosterone therapy still requires proper diagnosis and monitoring, warning against indiscriminate use.

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.

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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.

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.

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.

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.