FDA moves to lift black box warnings from menopause hormone therapies

The US Food and Drug Administration (FDA) is removing boxed warnings for cardiovascular disease, breast cancer and dementia from hormone replacement therapies used to treat menopausal symptoms, reversing a two-decade stance that followed the Women’s Health Initiative (WHI) study. The decision comes after a scientific review and public consultation, and aims to restore confidence in hormone therapy.

Health and Human Services Secretary Robert Kennedy Jr and FDA Commissioner Marty Makary announced the move in Washington, describing it as a “return to evidence-based medicine.” The agency said it will work with manufacturers to update product labels, though the endometrial cancer warning on estrogen-only therapies will remain.

The WHI’s 2002 findings had linked hormone therapy to higher risks of breast cancer, heart disease and stroke. But the FDA now says the study overstated those dangers because participants were, on average, 63 years old, much older than typical menopause onset, and received a formulation no longer in use.