Viewpoint

Updated Labeling for Menopausal Hormone Therapy

JAMA 10.1001/jama.2025.22259

November 10, 2025 at 11:10 AM EST

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This Viewpoint describes the US Food and Drug Administration’s intended label updates and removal of black box warnings for menopausal hormone therapy based on current evidence.

Corresponding Author: Martin A. Makary, MD, MPH, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993 (commissionersoffice@fda.hhs.gov).

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