Media Tip Sheet: FDA Removes Black Box Warning on Menopause Hormone Therapy


November 11, 2025

The FDA announced this week that it will remove the black box warning from all estrogen and progesterone hormone therapies for menopause, citing decades of new evidence showing the treatments are far safer — and more beneficial — than once believed.

The move marks a dramatic reversal of the agency’s 2002 stance, when an early clinical trial linked hormone therapy to breast cancer, stroke, and heart attack — data that experts now say was outdated and overstated the risks.

George Washington University experts are available to discuss this topic. If you would like to schedule an interview, please contact Katelyn Deckelbaum, katelyn [dot] deckelbaumatgwu [dot] edu (katelyn[dot]deckelbaum[at]gwu[dot]edu).

Kathryn Marko, is a board-certified obstetrician and gynecologist at The GW Medical Faculty Associates and an assistant professor of Obstetrics & Gynecology at GW School of Medicine and Health Sciences.

Linda Cassar, clinical associate professor at the GW School of Nursing, has worked primarily with the maternal/child health patient population over her 30 years as a nurse, working in labor and delivery, mother/baby, high-risk antepartum, and outpatient community perinatal education.

Amita N. Vyas, is an associate professor at the GW Milken Institute School of Public Health and Director for the MPH Maternal and Child Health program and the Center of Excellence in Maternal and Child Health.