FDA May Ease Warning on Hormone Therapy for Menopause Symptoms

Key Takeaways

The U.S. Food and Drug Administration is considering changes to a 20-year-old warning on menopause hormone therapy

Experts say the warning has discouraged safe use of treatment for hot flashes, poor sleep and other symptoms

Research suggests hormone therapy can be safer and more effective when started earlier in menopause

MONDAY, Oct. 6, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) is reviewing whether to change the warning label on hormone replacement therapy (HRT) drugs used to treat menopause symptoms, a move many experts say is long overdue.

“We are in serious discussions now about what to do about the black box warning, and I think you’ll hear something on it very soon,” FDA Commissioner Dr. Martin Makary said on CNN’s Chasing Life podca