11/10/2025
U.S. Food and Drug Administration (FDA) is initiating the removal of broad “black box” warnings from HRT (hormone replacement Therapy) products for menopause.
"As women go through menopause, the ovaries produce less estrogen and progesterone. FDA-approved HRT containing estrogen and progesterone (or estrogen alone as indicated for postmenopausal women without a uterus) can restore these declining hormones and relieve symptoms such as hot flashes, night sweats, sleep disturbances, and bone loss."
Randomized studies show that women who initiate HRT within 10 years of the onset of menopause (generally before age 60) have a reduction in all-cause mortality and fractures. Women may also reduce their risk of cardiovascular diseases by as much as 50%, Alzheimer’s disease by 35%, and bone fractures by 50 to 60%.
The FDA is NOT seeking to remove the boxed warning for endometrial cancer for systemic estrogen-alone products.
The U.S. Department of Health and Human Services (HHS) today announced historic action to restore gold-standard science to women’s health.