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Investing.com -- The U.S. Food and Drug Administration plans to remove its strictest "black box" warnings from hormone therapies used to treat menopause symptoms, according to FDA Commissioner Marty Makary.
In an opinion piece published in the Wall Street Journal on Monday, Makary announced the FDA’s request for drug manufacturers to remove these severe warnings from menopause treatments.
Hormone replacement therapy works by replenishing hormones, primarily estrogen, that decline during menopause, helping to relieve symptoms such as hot flashes and vaginal dryness.
Currently, all menopause treatments containing estrogen carry warnings about increased risks of strokes, blood clots, possible dementia, and breast cancer. A black box warning represents the FDA’s most severe label for prescription medications, indicating potentially fatal or serious side effects.
Makary, who convened a panel in July to examine these treatments, has argued that the breast cancer warning has inappropriately limited women’s access to these therapies.
"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 stated in a post on X.
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