The FDA removed boxed warnings tying menopausal hormone replacement therapies to increased risks of cardiovascular disease, breast cancer and probable dementia for six HRT products. The agency said it updated labeling following a comprehensive literature review and industry submissions. Commissioner Marty Makary framed the change as expanding access for symptomatic women; the move may shift prescribing patterns and influence patient uptake. Drugmakers and clinicians will watch how updated labels affect market demand and medico‑legal considerations.
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