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FDA panel reassesses hormone therapy warnings in menopause treatments
NBC News· 2025-07-18 16:00
FDA & HRT Treatment Overview - FDA is clarifying the use of hormone replacement therapy (HRT) for perimenopause and menopause, suggesting previous risk assessments may be overstated [1] - The central argument revolves around whether the benefits of HRT outweigh the risks, particularly concerning stroke, blood clots, dementia, and breast cancer [3][6][8] Risk Assessment & Black Box Warning - Current medication labels include a black box warning about increased risks of heart disease, heart attack, strokes, and breast cancer [2][5] - The FDA is considering removing the black box warning due to arguments that the benefits of HRT outweigh the risks [5][6] - A 2002 women's health initiative study, with an average participant age of 63, is being re-evaluated, as HRT is often prescribed to women in their late 40s and 50s [6] - The perceived risk of breast cancer from HRT is considered by some to be overblown [7] - Baseline risk of developing breast cancer is around 13% for women in the United States [3][4] Benefits of HRT - Potential benefits of HRT include reduced risk of dementia and Alzheimer's, prevention of bone loss, and alleviation of menopause symptoms like hot flashes, poor sleep, and brain fog [8] - Estrogen, a key component of HRT, aids neurotransmitter function, potentially lowering the likelihood of dementia and Alzheimer's [9][10]
