FDA removes menopause hormone therapy black box warnings

After an FDA panel was convened to review black box warnings on menopause hormone therapy, which includes both systemic and vaginal estrogen treatments, the FDA announced in November 2025 it would remove black box warnings from all hormone therapy products containing estrogen. Women considering hormone therapy should discuss their individual health risks with their doctor — such as a history of heart attack or stroke, a blood clot in the legs or lungs, hormone-sensitive cancer, active liver disease, and overall breast cancer and cardiovascular risks.