(Reuters) -The U.S. Food and Drug Administration is requesting drug manufacturers to remove its strictest “black box” warnings from hormone therapies given to women to treat menopause symptoms, Commissioner Marty Makary said in an opinion piece published in the Wall Street Journal on Monday.
Hormone replacement therapy for menopause replenishes the hormones, primarily estrogen, that decline with menopause to relieve symptoms like hot flashes and vaginal dryness.
All menopause treatments containing estrogen carry a warning that it increases the risk of strokes, blood clots and perhaps dementia. It also warns of the possibility of breast cancer.
Makary convened a panel in July to look at the treatments and has argued that the warning over breast cancer has wrongly prevented women from accessing it.
A black box warning is the most severe the FDA can place for a prescription medication, indicating serious or potentially fatal side effects.
“With the exception of vaccines or antibiotics, there’s no medication that can improve the health of women on a population level more than hormone replacement therapy,” Makary said in a post on X.
The U.S. Department of Health and Human Services will meet later on Monday to discuss actions to advance women’s health.
(Reporting by Christy Santhosh in Bengaluru; Editing by Shailesh Kuber)
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