FDA Lifts HRT Black Box Warnings 2025

The U.S. Food and Drug Administration (FDA) announced it is eliminating long-standing black box warnings on hormone replacement therapy (HRT) products designed to ease menopause symptoms. These strongest safety alerts, in place for over 20 years, highlighted risks like heart disease, stroke, breast cancer, and dementia, but recent evidence shows they overstated dangers for many women.

Health and Human Services Secretary Robert F. Kennedy Jr. called the change a return to “evidence-based medicine,” noting outdated studies created unnecessary fear. FDA Commissioner Marty Makary, MD, added that millions of women missed out on HRT’s benefits due to “distorted” warnings.

Why the Warnings Are Changing

Added in 2003 after the Women’s Health Initiative (WHI) study suggested elevated risks, the labels caused HRT prescriptions to drop by up to 45%. New analyses of data from women starting HRT within 10 years of menopause show benefits often outweigh risks, including up to 50% lower chances of heart disease, 35% reduced Alzheimer’s risk, and 50-60% fewer bone fractures.

The FDA requires manufacturers to revise labels on cardiovascular, breast cancer, and dementia risks but keeps warnings for endometrial cancer on estrogen-only systemic products. It also recommends starting HRT before age 60 or within a decade of menopause onset.

Impact on Menopause Care and Stigma

Experts predict this will boost HRT use for symptoms like hot flashes, night sweats, sleep issues, and vaginal dryness, addressing underutilization. “This restores trust in HRT for quality of life and healthy aging,” said OB-GYN Sheryl Ross, MD.

Reproductive endocrinologist Nataki Douglas, MD, views it as a “key step” for better clinician education and patient-provider talks, potentially increasing specialist referrals. With 6,000 U.S. women entering menopause daily, this could transform access to relief.

Next Steps for Women and Doctors

HRT decisions should be personalized, balancing benefits and risks with a healthcare provider. The FDA is also approving new non-hormonal options and generics like conjugated estrogens tablets. This shift prioritizes data over fear, empowering women during menopause.