FDA to Remove 'Black Box' Warnings From Menopause Hormone Therapy. Here's Why.

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 .

The Conversation US asked Genevieve Hofmann, a women's health nurse practitioner at the University of Colorado Anschutz Medical Campus, to explain how the decision will affect health care for people going through menopause or postmenopause.

How did the FDA's decision come about?

When people think of hormone therapy for menopause, they generally think of systemic estrogen and progestogens – for example, pills or patches that deliver hormones thr