Consider This from NPR FDA reverses decades of guidance on hormone therapy for menopause
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Nov 10, 2025 Marty McCary, the FDA Commissioner, discusses the agency's groundbreaking decision to remove the black box warning on estrogen therapy for menopause. Joanne Pinkerton, a menopause specialist, highlights the clinical benefits of hormone replacement therapy, especially when started early. They delve into how the 2002 Women's Health Initiative study led to a decline in therapy, and McCary reassesses the risks associated with hormone therapy. The conversation also addresses concerns about access and potential overuse after the warning's removal.
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Fear From Early Study Shaped Two Decades
- The 2002 WHI study triggered a dramatic drop in hormone therapy use due to fear and media coverage.
- Over time, further research showed benefits and more nuanced risks, prompting reevaluation.
Patient Regains Life After Vaginal Estrogen
- Joanne Pinkerton described patients who were severely debilitated by menopause and improved on hormones within weeks.
- She told of a horseback-riding patient who resumed riding and stopped recurrent UTIs after starting vaginal estrogen.
Timing Determines Risk And Benefit
- FDA Commissioner Marty McCary argues the risks depend on timing relative to menopause onset.
- When started within 10 years of menopause, estrogen shows cardiovascular and cognitive benefits and reduces fractures.