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Health|F.D.A. Panel to Reassess Hormone Therapy Warnings
https://www.nytimes.com/2025/07/17/health/hormone-therapy-menopause-fda.html
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Dr. Marty Makary, the agency’s commissioner, has said too many women avoid menopause treatments because the risks have been overstated.
July 17, 2025, 5:03 a.m. ET
Dr. Marty Makary, commissioner of the Food and Drug Administration, will convene an expert panel on Thursday that he said will “set the record straight” about hormone therapy for menopause, a treatment that he champions despite mixed findings about its risks and benefits.
Although there is no public agenda, the panel is expected to discuss whether the risks have been overstated, deterring women who might benefit.
All menopause treatments containing the hormone estrogen carry a black box warning that the medication should not be used to prevent cardiovascular disease or dementia, and that it increases the risk of strokes, blood clots and probable dementia.
The label also warns of the possibility of breast cancer.
But proponents like Dr. Makary say there’s evidence that hormone therapy — approved for the treatment of symptoms like hot flashes — may prevent cognitive decline, heart disease and some cancers, in addition to conferring benefits that are not in dispute, like reducing osteoporosis-related fractures.
Dr. Makary has dismissed findings of a heightened risk of breast cancer in women who took combined estrogen and progestin, saying the research caused a “breast cancer scare” that has deterred women from getting a useful treatment.
“There’s probably no medication that improves the health outcomes of a population more than hormone replacement therapy for women who start it within 10 years of the onset of menopause,” except perhaps antibiotics, Dr. Makary said on a podcast.
