Overview

• FDA Commissioner Martin Makary said the agency is in serious discussions about the black box warning and indicated an announcement could come soon.
• An FDA advisory panel in July recommended removing the warning for low‑systemic estrogen options such as creams, tablets, or rings.
• The current label, applied since 2003 to all estrogen menopause drugs, warns of breast and uterine cancer, blood clots, stroke, and dementia risk in women over 65.
• Hormone therapy prescriptions have dropped by more than 70% since the warning was added, and many experts say fear has left symptoms untreated.
• Evidence suggests risks differ by formulation and timing, with systemic pills linked to higher risks than patches or creams, while some clinicians urge caution on using HRT for long‑term disease prevention without more research.