FDA reverses decades-old warning on hormone therapy products for menopause

WASHINGTON — The Food and Drug Administration is reversing a 2003 decision that put a stringent warning on hormone therapy products for menopausal women, saying that the treatments offer heart, brain, and bone health benefits. 

Commissioner Marty Makary wrote in a Wall Street Journal op-ed on Monday that the FDA is removing black box warning labels from all-combined estrogen-progestogen, estrogen-only, other estrogen-containing, and progestogen-only products used for hormone therapy. The agency said it’s asking companies to remove the warnings from their products, specifically mentions of cardiovascular, dementia, and breast cancer risk.

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