Hormone Therapy and Menopause: Why the FDA Removed Its Black Box Warning
For more than two decades, hormone therapy for menopause was widely viewed as dangerous. Millions of women were discouraged from using estrogen or combined hormone replacement therapy (HRT), often being told the risks outweighed any potential benefit. In 2025, the U.S. Food and Drug Administration (FDA) made a landmark decision: it removed the long-standing black box warning from hormone-based menopause drugs. The move has reignited debate over whether a generation of women was misled about hormone therapy — and how menopause treatment should be approached today. The Women’s Health Initiative and the Rise of Hormone Therapy Fear The shift in public perception began in 2002 with early findings from the Women’s Health Initiative (WHI), a large U.S. government-funded study examining hormone replacement therapy in postmenopausal women. Initial headlines warned that hormone therapy increased the risk of: Breast cancer Heart attacks Stroke and blood clots Dementia Pres...