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The FDA is removing black box warnings from menopause hormone therapies for women under 60 or within 10 years of menopause, citing updated evidence of low risk.
The FDA is removing black box warnings from menopause hormone therapies, citing updated science showing risks like blood clots and heart issues are minimal for women under 60 or within 10 years of menopause.
The change, effective by mid-2026, reflects reanalysis of older studies and recognizes that transdermal forms (patches, gels) carry lower risks than oral pills.
Topical vaginal estrogen, previously mislabeled, is also exempt.
The move aims to reduce fear-driven avoidance and support personalized treatment based on age, timing, and health history.
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La FDA está eliminando las advertencias de caja negra de las terapias hormonales de la menopausia para mujeres menores de 60 años o dentro de los 10 años de menopausia, citando evidencia actualizada de bajo riesgo.