The FDA is removing black box warnings from menopausal hormone replacement therapy products, citing evidence that benefits outweigh risks for most women when treatment starts within ten years of menopause onset.
The agency is requesting that companies update product labeling to remove references to risks of cardiovascular disease, breast cancer, and probable dementia. The FDA is not removing the boxed warning for endometrial cancer for systemic estrogen-alone products.
The FDA’s labeled recommendation will be to start HRT within 10 years of menopause onset or before 60 years of age for systemic HRT.
Studies have provided evidence that starting HRT within ten years of menopause onset can reduce risk of all-cause mortality and fractures. HRT has been associated with a 50% reduction in heart attack risk, 64% reduction in cognitive decline, and 35% lower risk of Alzheimer’s, according to the FDA.
An analysis of 30 trials with 26,708 women participants found HRT was not associated with increased cancer mortality. Women who start HRT before age 60 appear to have a decreased mortality risk.
HRT is FDA-approved for relief from menopausal symptoms including hot flashes and night sweats, symptoms due to vulvovaginal atrophy or genitourinary syndrome of menopause, and prevention of osteoporosis.
The action follows the FDA’s assessment of current literature, including a reanalysis of data from younger cohorts of patients who initiated HRT within ten years of menopause onset.
