I treat menopause and its symptoms, and hormone replacement therapy can help – here’s the science behind the FDA’s decision to remove warnings

Reanalyses of earlier research have shown that hormone therapy is safe and effective for many women going through menopause. monkeybusinessimages/iStock via Getty Images Plus

For more than 20 years, hormone therapy for menopause has carried a warning label from the Food and Drug Administration describing the medication’s risk of serious harms – namely, cancer, cardiovascular disease and possibly dementia.

On Nov. 10, 2025, the FDA announced that drugmakers should remove these “black box” safety warnings.