FDA Expert Panel Update on Hormone Replacement Therapy (HRT)

Outdated Warnings Under Review:

The FDA convened a panel of menopause experts to reevaluate the black box warnings on hormone replacement therapies, especially low-dose vaginal estrogen and systemic estrogen therapy.

New Evidence Supports Safety & Benefits:

• Estrogen started within 10 years of menopause can reduce heart attack risk by 25–50%, even more than statins.
• Low-dose vaginal estrogen is safe and does not increase the risk of breast cancer, stroke, or blood clots.

Benefits include improved bone health, cognitive support, vaginal and urinary symptoms, and possibly mood.

Panel Recommendations:

• Remove or soften the black box warning on menopausal hormone therapy.
• Educate clinicians and patients using modern research, not outdated studies like the 2002 Women’s Health Initiative (WHI).
• Expand research and access to testosterone therapy in women where appropriate.

Why It Matters

For years, millions of women have avoided hormone therapy due to fear-based warnings. This panel confirms what many clinicians already know: when used appropriately and started early, HRT can be a safe and effective tool to improve quality of life and reduce long-term health risks.

Learn More

• FDA Meeting Details & Webcast:
• FDA Expert Panel Info & Video
• News Articles & Medical Coverage:
• Axios Coverage – July 18, 2025
• Managed Healthcare Executive Summary
• Urology Times – Expert Commentary

Have Questions About Hormone Therapy?

Let’s talk. Schedule a consultation to explore safe, evidence-based options that support your long-term wellness.