Men with low testosterone will soon have greater access to hormone replacement therapy following new changes to product labeling from the Food and Drug Administration.
The Department of Health and Human Services announced on Thursday that the drug regulating agency would be updating labeling information related to the cancer risks of testosterone replacement, as well as removing cautionary notes on the safety and efficacy of the treatment for age-related low testosterone.
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Assistant Secretary for Health Brian Christine, a urologist by training and a leading voice in men’s health initiatives at HHS, said in a press release that the labeling change would give patients and providers “accurate, up-to-date information when considering treatment options.”
“As our understanding of testosterone therapy continues to evolve, prescribing information should reflect the best available science,” Christine said.
In 2015, the FDA required testosterone replacement therapy, or TRT, product labels to include a limitation of use saying that risks to cardiovascular health did not outweigh the potential benefits for men with low libido or low testosterone without a known structural or genetic cause.
But a landmark clinical trial in 2023 of more than 5,200 men found no meaningful increase in the risk of major adverse cardiovascular events, including heart attack and stroke.
The announcement on Thursday said the agency reviewed the 2023 trial and additional evidence to conclude safety and efficacy warnings were no longer warranted except in cases of advanced prostate cancer.
The FDA took similar action under the leadership of the former commissioner, Dr. Marty Makary, to loosen restrictions on hormone replacement therapy for menopausal and postmenopausal women after new evidence indicated earlier studies overstated the increased risks of heart disease and breast cancer.
Christine has been at the center of updating men’s health programs at HHS since he was confirmed to the position in December. He and others in the Cabinet argue men need greater targeted attention from public health leadership.
Women in the United States live six years longer than men on average, with the male life expectancy reaching only 73 as of 2023, compared to women’s 79.
Although rates of depression are roughly the same between the sexes, the suicide rate for men is four times higher than it is for women. American men are also three times more likely to die from opioid use and have higher rates of alcohol abuse.
In February, Reps. Troy Carter (D-LA) and Greg Murphy (R-NC) introduced the State of Men’s Health Act, which would require the Government Accountability Office to conduct a study and issue a report to Congress on men’s health, including health disparities experienced by men.
The bill would also require HHS to create an Office of Men’s Health, mirroring the Office on Women’s Health that was created in 1991.
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HHS Secretary Robert F. Kennedy Jr. celebrated the FDA’s testosterone labeling change as a culminating achievement of Men’s Health Month in June, saying in a press release that his department is “putting science back at the center of men’s healthcare.”
“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,” Kennedy said.
