The FDA announced that it will initiate the removal of the boxed warning—the agency’s most serious safety label—from many hormone replacement therapies (HRT) used in managing menopausal symptoms. This change is based on a comprehensive review of the scientific evidence, including more recent data showing that when hormone therapy is started earlier in menopause (for example, within 10 years of menopause onset or before age 60), the risks of cardiovascular disease, breast cancer, and dementia appear lower than previously assumed.
The warning originated after the landmark Women’s Health Initiative (WHI) in the early 2000s, which found increased risks — in an older cohort of women using older formulations of hormone therapy — of stroke, heart attack, breast cancer and other events.
With this update, the FDA aims to ensure that outdated broad warnings aren’t deterring women and their doctors from using hormone therapies when the benefits may outweigh the risks for appropriate patients. It will still retain warnings in more specific cases (for example, for endometrial cancer risk with estrogen-only systemic therapy)
