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FDA Commissioner on lifting warnings on hormone therapy for menopause

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November 11, 2025

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The Food and Drug Administration says it is removing the black box safety warnings from all hormone therapy creams, pills and other treatments prescribed to ease the symptoms of menopause and perimenopause.

The prominent warnings said these therapies could raise the risks for some cancers, dementia, heart attacks and strokes.

It was time for a change, Makary told NPR's All Things Considered, because women have "been denied or never offered hormone replacement therapy despite the profound short term and long term benefits."

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FDA Commissioner on lifting warnings on hormone therapy for menopause · Npr · Sentinel