The U.S. Food and Drug Administration announced it will work with manufacturers to remove or narrow boxed warnings on hormone replacement therapies for menopause, reversing long-standing labeling that linked HRT to high risks of breast cancer and cardiovascular disease. Agency officials framed the change as an effort to update warnings based on more recent evidence and improve patient access to symptom-relief therapies. The announcement came from HHS and the FDA at a Nov. 10 news conference and was reported in national outlets. The FDA’s commissioner and HHS leaders emphasized reassessment of older trial data and the potential to reduce undertreatment of menopausal symptoms while noting that updated labeling will still require appropriate clinical guidance and risk discussion. Drugmakers are expected to submit label-change applications; clinicians and patient advocates told reporters the move could shift prescribing patterns and insurance coverage for long-term menopausal care.
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