Menopausal hormone therapy use dropped sharply after the Women’s Health Initiative—from more than 20% of menopausal women to under 5% within a decade—and has remained low even as evidence has evolved.
That’s the backdrop for a JAMA Perspective in which lead author Deborah Bartz, MD, MPH, of the Department of Obstetrics and Gynecology at Brigham and Women’s Hospital, and colleagues, used the FDA November 2025 removal of several black box warnings regarding the risks of cardiovascular disease, stroke, dementia, and breast cancer on menopausal hormone therapy (MHT) to highlight an opportunity to improve care. The Perspective authors framed the label change as both an opportunity and a responsibility for clinicians.
Over the past two decades, research has filled previous knowledge gaps and clarified that when MHT is initiated prior to 60 years or within 10 years of menopause, its benefit-risk profile is favorable. The updated FDA labeling reflects this evidence, removing prior guidance to use the lowest dose for the shortest duration and expanding safety language to distinguish between formulations and routes of delivery.
The Perspective authors also pointed to gaps in menopause education and clinical practice. Care has often been concentrated among women's health clinicians who have pursued specialized training, while many clinicians who routinely see middle-aged women may not be systematically screening for symptoms. They emphasized that symptoms can begin years before menopause, underscoring the importance of earlier recognition.
Questions around access and equity remain. Coverage often varies across insurance plans, and newer or nonhormonal options may require prior authorization. Meanwhile, the demand for care has been increasing, alongside growing interest from both patients and clinicians.
The Perspective authors emphasized the need for a prompt to examine whether current practices are benefitting women who need care rather than introducing a new standard of care. For clinicians who treat middle-aged women, the FDA label change reinforces the need for routine symptom assessment, individualized risk-benefit discussions, and greater familiarity with the range of available treatment options.
"While newly incorporating menopause symptom screening and treatment into one’s medical practice may seem challenging initially, with dedicated continuing education with evidence-based sources and regular practice experience, one can better integrate hormone therapy options and personalized, shared decision-making into their routine care of midlife women," concluded the Perspective authors.
Senior Perspective author JoAnn E. Manson, MD, DrPH, reported receiving grants from the National Institutes of Health. No other disclosures were reported.
Source: JAMA
