The U.S. Department of Health and Human Services (HHS) announced a major policy shift today aimed at re-establishing what it described as gold-standard scientific guidance in women’s health. After more than 20 years of uncertainty and public concern surrounding hormone replacement therapy (HRT), the U.S. Food and Drug Administration (FDA) has begun the process of eliminating the broad black box warnings appearing on menopause-related HRT medicines.
HRT has long been used to ease menopausal symptoms, but its usage fell sharply in the early 2000s after the FDA issued boxed warnings based on a Women’s Health Initiative study. That study reported a statistically non-significant rise in breast cancer diagnoses, involved participants with an average age of 63 years, well beyond the typical onset of menopause, and used a hormone formulation that is no longer standard.
Following a full scientific review, an expert panel meeting in July, and a public comment process, the FDA is now moving to remove those broad black box warnings. The agency is coordinating with manufacturers to revise product labels and eliminate references to risks involving cardiovascular disease, breast cancer, and probable dementia. One exception remains: the boxed warning for endometrial cancer will stay in place for systemic estrogen-alone medications.
As estrogen and progesterone decline during menopause, FDA-approved HRT, whether estrogen-progesterone combinations or estrogen alone for women without a uterus, can be used to address symptoms such as night sweats, hot flashes, bone loss, and sleep disruption.
Randomized studies indicate that starting HRT within 10 years of menopause onset, typically before age 60, can lower all-cause mortality and fracture risk. Women may also see reductions of up to 50% in cardiovascular diseases, a 35% decrease in Alzheimer’s disease, and a 50 to 60% drop in bone fractures. The FDA’s guidance continues to recommend initiating systemic HRT before age 60 or within a decade of menopause onset, with final decisions resting between patients and their clinicians.
Alongside the warning changes, the FDA has approved two new treatments for menopause-related symptoms. One is a generic version of Premarin (conjugated estrogens), marking the first such approval in more than 30 years and expected to improve access while matching the brand’s quality and effectiveness. The second is a non-hormonal therapy designed for moderate to severe vasomotor symptoms, offering an alternative for women who cannot or prefer not to take hormone therapy.
