The U.S. Department of Health and Human Services wants to remove some of the stigma from testosterone treatment.

The agency, through the U.S. Food and Drug Administration, is asking manufacturers to take off warnings that have long appeared on hormone replacement therapy labels for older men whose testosterone levels decline naturally with age, it said in a statement Thursday.

The FDA a decade ago required drugmakers to study the impact of testosterone use on men at high risk of heart problems. They also had to note that the safety and efficacy of the products had not been established due to limited evidence. Now, those warnings are no longer needed, the agency said.

“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,” said Health Secretary Robert F. Kennedy Jr., a self-described testosterone user and proponent.

Testosterone replacement in men with low levels is known to improve sexual function, lean body mass, bone mineral density and mood, according to the Cleveland Clinic. It can also cause a range of side effects, including acne, fluid retention, breast enlargement, smaller testicles, urinary symptoms, elevated red blood cell counts and suppressed sperm production, which can impair fertility.

The new recommendation follows a review of new clinical data and scientific evidence, the agency said. Researchers in 2023 found testosterone had about the same effect on heart attacks, strokes and death from cardiovascular disease as a placebo in a study of more than 5,000 men published in the New England Journal of Medicine. The trial, funded by AbbVie Inc. and others, did find a higher rate of atrial fibrillation, kidney damage and pulmonary embolism in those taking testosterone.

The FDA also said it would update safety information on prostate health, which previously suggested that testosterone replacement therapy may increase the risk of cancer, following a review of scientific evidence. The new labeling recommends prescribers assess cancer risk before hormone therapy and monitor patients during treatment.

The changes could make physicians more comfortable offering replacement therapy to older men with symptoms of low testosterone. This is potentially a boon for telehealth companies like Hims & Hers Health Inc. that sell it, and to manufacturers and clinics that have long argued the risks of treatment have been overstated.

Testosterone has become increasingly common in recent years, with devotees including Kennedy and podcast host Joe Rogan touting the therapies. In a 2023 podcast interview with Lex Fridman, Kennedy said he was on an anti-aging protocol that included testosterone replacement therapy.

Kennedy has frequently warned of a men’s health crisis, pointing to studies suggesting sperm counts have declined over the past several decades. He also argues that testosterone levels among younger men are falling, both claims that remain the subject of scientific debate.

In February, the FDA also made it easier for women to receive estrogen replacement therapy, a controversial hormone that many women took as they aged, until a study raised questions about its risks. While those doubts were largely calmed by further analysis, demand for the hormone that reduces symptoms like hot flashes are only now starting to significantly recover.

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