The FDA Has Removed The Black Box Warning From Some Menopause Hormone Therapy Labels: Here’s What That Really Means
On November 10, 2025, the U.S. FDA announced it is initiating removal of the boxed (“black box”) warnings from menopause hormone therapy (MHT) product labeling — specifically removing class-wide references to cardiovascular disease, breast cancer, and “probable dementia.” What changed (and what didn’t) What the FDA is removing from boxed warnings (for menopausal hormone therapy […]