After Two Decades of Black Box Warnings, Menopause Care Is Breaking Free
In November 2025, the FDA announced it would begin the process of removing the black box warning from menopausal hormone therapy (MHT), marking a significant moment in women's health.
The warning was introduced in 2003 following the publication of the Women's Health Initiative study, which raised concerns about potential long-term risks associated with hormone therapy. The impact was immediate: prescription rates declined, patient anxiety increased, and many women moved away from a treatment that had long been used to manage menopause symptoms.
Over the next two decades, researchers, clinicians, and women's health advocates continued to examine the data, challenge assumptions, and deepen scientific understanding of menopause care. Additional research and clinical experience led many experts to conclude that the original findings did not fully reflect the experiences and needs of all women.
The FDA's decision reflects years of scientific review, advocacy, and collaboration across the women's health community. It also highlights an important truth: meaningful progress in women's health takes time.
As awareness grows and access to evidence-based menopause care improves, this change may help more women have informed conversations with their healthcare providers about available treatment options.
For those working across women's health, the removal of the black box warning represents more than a regulatory update—it is a reminder that persistent advocacy, better science, and collaboration can drive meaningful change.
Read Rachel Braun Scherl's full Forbes article to learn more about the history behind the black box warning and what this milestone means for the future of menopause care.