FDA Approves HRT Label Changes
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By
February 12, 2026
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2 min
The FDA has updated the boxed warning for select menopausal hormone therapies, removing specific risk statements related to cardiovascular disease, breast cancer, and probable dementia. This decision follows a review of scientific data and aims to provide women with accurate information about the benefits of hormone replacement therapy (HRT). The approved therapies, which address various menopausal symptoms, are vital as many women do not utilize available treatments despite significant health benefits, especially when started within 10 years of menopause onset.
1. FDA updated boxed warning on hormone therapies for menopause. 2. Cardiovascular disease and breast cancer risks removed. 3. Four categories of hormone therapy are included. 4. Efficacy is best when therapy starts within 10 years post-menopause. 5. Over 41 million women aged 45-64 exist, but very few use hormone therapy. 6. Related symptoms can greatly affect quality of life. 7. FDA emphasizes science-based decisions for women's health.
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