On November 10, 2025, the U.S. Food and Drug Administration (FDA) announced a significant change regarding hormone replacement therapy (HRT) for menopause by removing the longstanding black box warnings from these medications. This move marks a reversal of a decision made in the early 2000s, when studies linked hormone therapies to increased risks of breast cancer, heart disease, and stroke in some women. The FDA’s black box warning is the strictest safety alert a medication can carry, typically reserved for treatments with serious or life-threatening risks. FDA Commissioner Marty Makary openly criticized the prior use of these warnings on menopause hormone therapies as unscientific during a press conference announcing the update.
Menopause hormone therapy has long been a contentious issue in women’s health. The therapies, which deliver synthetic versions of estrogen or a combination of estrogen and progesterone, aim to alleviate common menopausal symptoms such as hot flashes, night sweats, and mood changes. They are administered in various forms, including oral pills, skin patches or gels, and vaginal rings. Initially, in the 1960s and particularly through the 1990s, hormone therapy was widely embraced as an effective treatment for menopause symptoms and was thought to reduce the risk of osteoporosis. However, the landscape shifted dramatically in the early 2000s following findings from the Women’s Health Initiative (WHI)—a major, long-term study funded by the National Institutes of Health—that associated hormone therapy with heightened risks of breast cancer, cardiovascular disease, and stroke in some women. This led the FDA to impose black box warnings on all hormone therapies prescribed for menopause symptoms, which in turn caused a sharp decline in their use.
Today’s FDA decision reflects a growing re-evaluation of those earlier findings. Experts have come to understand that the risks identified in the WHI were largely overstated, particularly for younger women and those using newer formulations of hormone therapies. Nanette Santoro, an obstetrician-gynecologist at the University of Colorado Anschutz and a lead WHI researcher, welcomed the change, emphasizing that many women have been undertreated for menopausal symptoms and continue to suffer in silence. “There’s been a growing appreciation that women are undertreated with hormones,” she said, noting that subsequent research has failed to find strong evidence of harm from hormone therapies in younger women or with modern drug formulations. According to Santoro, the overall evidence suggests “there’s no big signal either way—there’s no big harm, and there’s no big health benefit” for older hormone formulations.
Despite this, some officials and advocates have made more expansive claims about hormone therapy’s benefits. Deputy Secretary of Health and Human Services Jim O’Neill stated that more women could reduce their risks of fractures, heart disease, immune decline, and cognitive disorders, while “extending their vigor” through hormone therapy. FDA Commissioner Makary and Health and Human Services chief Robert F. Kennedy, Jr. cited studies suggesting hormone therapy might reduce general mortality and lower risks of cardiovascular disease and Alzheimer’s disease. However, experts like Santoro caution that the current scientific evidence does not robustly support such broad benefits, urging a more nuanced understanding of hormone therapy’s effects.
The FDA’s recent reconsideration comes amid broader scrutiny of past regulatory decisions by Makary and Kennedy, including those related to vaccines. In July, a panel of experts convened to review the latest scientific evidence on the risks and benefits of hormone therapy for menopause, helping inform the FDA’s updated guidance. Notably, the FDA’s decision does not remove all warnings on hormone therapies; certain estrogen-only treatments will continue to carry black box labels highlighting risks of endometrial or uterine cancer. Gynecologic oncologist Kemi Doll from the University of Washington points out that these cancer risks have historically received less attention, underscoring the importance of informing patients with a uterus about the potential dangers of estrogen-only therapy without progesterone.
Menopause itself is a natural biological transition characterized by a decline in estrogen production and the cessation of menstrual periods for 12 months or more. Hormone therapies work by supplementing estrogen levels, sometimes combined with progesterone, to relieve bothersome symptoms and improve quality of life. While early enthusiasm for hormone therapy was rooted in its potential to prevent osteoporosis, the discovery of associated health risks led to more cautious use. The WHI’s findings, which mainly involved women in their 70s using an older form of hormone therapy, triggered the FDA’s black