FDA removes most menopause therapy boxed warnings
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On Nov. 10, 2025, the FDA said it will ask manufacturers to remove most ‘black box’ safety warnings from hormone drugs used to treat menopause symptoms, reflecting updated evidence on risks and benefits. The endometrial cancer boxed warning will remain on estrogen‑only systemic products, and clinicians emphasize therapy choices should be individualized, especially for women under 60 or within 10 years of their last period.
FDA
Women's Health