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FDA weighs updating HRT warning, citing lower risks for younger women and new evidence.
The FDA is considering updating the 2003 black box warning on hormone replacement therapy (HRT) for menopause, citing new evidence that risks like cancer and blood clots may not apply to younger women starting treatment near menopause.
The current warning, based on the Women’s Health Initiative study, has contributed to a 70% drop in prescriptions.
An FDA advisory panel recommended revising or removing the warning, especially for localized estrogen treatments like creams and rings, which may pose lower systemic risks.
Experts say the outdated warning has caused unnecessary fear and limited access to effective symptom relief.
The FDA is expected to announce its decision soon, urging women to consult healthcare providers to weigh individual risks and benefits.
La FDA considera actualizar la advertencia HRT, citando menores riesgos para las mujeres más jóvenes y nuevas evidencias.