F.D.A. Will Remove Black Box Warnings From Hormone Treatments for Menopause
November 10, 2025

(New York Times) – The benefits of hormone replacement have been underappreciated, Dr. Marty Makary, the agency’s commissioner, said on Monday. Critics described evidence for the change as insufficient.
The Food and Drug Administration will remove the so-called black box warning from all hormone replacement products containing estrogen, Dr. Marty Makary, the agency’s commissioner, announced on Monday.
The labels will be rewritten with age-specific guidance indicating that there are long-term health benefits if treatment is begun within 10 years of the onset of menopause.
The changes, expected within six months, represent a radical turnabout in what women have been told about hormone replacement therapy. (Read More)