The food and drug Administration is poised to remove the black box warning from hormone therapy (HRT) prescriptions, a move anticipated to broaden access to treatment for menopause symptoms. The change, announced November 10, 2025, stems from a reevaluation of decades-old data and a growing understanding of the nuanced risks and benefits of HRT for different populations.
For years,the black box warning-the most stringent caution on prescription drugs-linked HRT to increased risks of blood clots,stroke,and certain cancers. This warning substantially curtailed HRT prescriptions, leaving many women to manage debilitating menopause symptoms without a widely accepted treatment option. The FDA‘s decision reflects updated research suggesting the risks are lower than previously believed, particularly for women initiating HRT closer to the onset of menopause. The alteration is expected to spark debate among medical professionals and patient advocates regarding the appropriate use and long-term effects of hormone therapy.
According to a November 11, 2025, news release from the American College of Obstetricians and Gynecologists (ACOG), ACOG President Dr. Christopher Zahn stated the label change will “increase access to hormone therapy for those who may benefit.” The organization has long advocated for a more balanced assessment of HRT’s risks and benefits.
However, the decision isn’t without its critics. an article published November 10, 2025, in Mother Jones by Butlet K and McShane J, highlighted potential problems with the FDA’s declaration, raising concerns about the complexities of individual risk factors and the need for continued research.
The FDA’s move comes as awareness of menopause and its impact on women’s health gains momentum. The agency anticipates the revised labeling will empower physicians to have more informed conversations with patients about HRT, allowing for individualized treatment plans based on a comprehensive evaluation of risks and benefits.
