The U.S. Department of Health and Human Services (HHS) today took a historic step to bring evidence-based science back to women’s health. Following over 20 years of fear and misinformation around hormone replacement therapy (HRT), the U.S. Food and Drug Administration (FDA) is beginning the process of removing broad “black box” warnings from menopause-related HRT products.
HRT has been used for many years to manage menopausal symptoms, but its use declined sharply in the early 2000s after the FDA added boxed warnings based on a Women’s Health Initiative study that reported a statistically non-significant rise in breast cancer diagnoses. Notably, the study involved women with an average age of 63 well beyond typical menopause and used a hormone formulation that is no longer standard today.
The FDA is moving to remove the boxed warnings after an extensive review of scientific evidence, an expert panel meeting in July, and a public comment period. The agency is now working with manufacturers to update product labels, eliminating outdated references to risks such as cardiovascular disease, breast cancer, and probable dementia. The boxed warning for endometrial cancer will remain for systemic estrogen-only therapies.
Leaders stressed that women deserve clear, evidence-based guidance on menopause treatments. Secretary Kennedy highlighted that outdated science and bureaucracy have limited understanding of HRT, while FDA Commissioner Makary noted that distorted risk perceptions have denied millions meaningful benefits, emphasizing that women’s health decisions should be data-driven, not fear-driven.
As women transition through menopause, their ovaries produce lower levels of estrogen and progesterone. FDA-approved hormone replacement therapy (HRT), which may include both estrogen and progesterone or estrogen alone for postmenopausal women without a uterus can help replenish these hormones and alleviate symptoms such as hot flashes, night sweats, sleep problems, and bone density loss.
“Estrogen plays a vital role in nearly every aspect of women’s health from the brain and bones to the heart and muscles,” said ARPA-H Director Alicia Jackson, Ph.D. “Removing the black box warning, based on the strongest scientific evidence, is a major advancement that will help millions of women achieve healthier, longer lives.”
Randomized studies showed that women who start taking HRT within 10 years of the onset of menopause have witnessed a reduction in all causes of mortality & fractures. In Addition to reducing the chances of cardiovascular diseases by as much as 50%, Alzheimer’s disease by 35%, and bone fractures by 50 to 60%.
Alongside removing boxed warnings, the FDA is expanding treatment options for menopause with two new approvals. The first is a generic version of Premarin (conjugated estrogens) the
first in over 30 years. This approval is expected to improve affordability and access while offering the same quality, safety, and effectiveness as the original product.
The second approval introduces a non-hormonal therapy for moderate to severe vasomotor symptoms, such as hot flashes. This gives women who cannot or prefer not to use hormone therapy an effective alternative for symptom relief.
Learn more: FdaHHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy
