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FDA removes key warnings from menopausal hormone therapy labels based on new evidence.
The FDA has approved updated labels for six menopausal hormone therapy products, removing boxed warnings about cardiovascular disease, breast cancer, and probable dementia.
The change, based on a review of current evidence, aims to provide more accurate, balanced information to help women make informed decisions.
The updated labels apply to systemic and topical HRT options used for hot flashes, vaginal dryness, and bone loss.
The FDA noted that women starting HRT within 10 years of menopause may have lower mortality and fracture risk.
Health officials emphasize discussing options with providers.
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La FDA elimina las advertencias clave de las etiquetas de terapia hormonal menopáusica basadas en nuevas evidencias.