Overview

• FDA Commissioner Martin Makary said the agency is in serious discussions and that an update is coming soon, speaking on CNN's Chasing Life podcast.
• The boxed warning has appeared since 2003 on all estrogen therapies, flagging risks such as breast and uterine cancer, blood clots, stroke, and dementia in women over 65.
• The warning was based on Women’s Health Initiative results in older women, while later analyses suggest lower risks for those who start therapy closer to menopause.
• Use of hormone therapy has fallen by more than 70% since the warning, dropping from roughly 1 in 4 postmenopausal women in the late 1990s to about 1 in 25 today.
• Experts note risks vary by formulation, with pills linked to higher risk than patches or creams, and some urge caution against promoting long-term preventive uses without more research.