FDA Lifting Warnings on Hormone Therapy for Menopause

November 10, 2025
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Hormone-based drugs used to treat hot flashes and other menopause symptoms will no longer carry a bold warning label about stroke, heart attack, dementia and other serious risks, the U.S. Food and Drug Administration announced Monday.

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.

"We now have a more nuanced understanding, and we want to put that fear machine in its proper context and let people know that there are tremendous long-term health benefits," Makary said.

The prominent warnings said these therapies could raise the risks for some cancers, dementia, heart attacks and strokes. That, FDA Commissioner Marty Makary told CBS News' Norah O'Donnell, scared women from using drugs that could in fact improve their health.

Doctors had gone back and forth about the risks versus benefits of hormone replacement therapy for years. In 2002, researchers rang the alarm about them because ...

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