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FDA Reverses Decades-Old Menopause Hormone Warnings
25 Feb
Summary
- FDA asks drugmakers to remove 'black box' safety warnings on hormone therapy.
- New analysis shows hormone therapy is safe for most women under 60.
- Topical vaginal estrogen's safety was previously overlooked by warnings.
The Food and Drug Administration (FDA) announced on November 10, 2025, that it will request drug manufacturers remove the "black box" safety warnings from menopause hormone therapy. These warnings, which have been in place for over 20 years, were initially added due to concerns about cancer, cardiovascular disease, and dementia.
Earlier studies, particularly the Women's Health Initiative results from 2002, led to a significant decrease in hormone therapy prescriptions. However, subsequent reanalyses and newer research have demonstrated that systemic hormone therapy is generally safe for most individuals, especially when initiated early in menopause.
Newer evidence suggests that the risks and benefits of systemic hormone therapy depend on factors like the timing of initiation, type, dose, and duration of use. Hormone therapy is considered safer for women under 60 or within 10 years of their last menstrual period, potentially even decreasing overall mortality in this group.
Conversely, starting hormone therapy more than 10 years after menopause may increase cardiovascular risk, a concept referred to as the timing hypothesis. Delivery methods also matter; transdermal patches, gels, or sprays are associated with lower risks of blood clots compared to oral pills.
The FDA's decision also addresses topical vaginal estrogen therapies, used to treat genitourinary syndrome of menopause. These treatments, which include creams and inserts, were wrongly included under the broad black box warnings despite their excellent safety record and localized application. This change is expected to alleviate provider reluctance and improve patient access to effective treatments for symptoms like vaginal dryness and urinary issues.
This regulatory shift is anticipated to reduce anxiety for both clinicians and patients regarding hormone therapy. While careful consideration of candidacy for systemic hormone use remains important, the updated evidence supports its safety for the majority, encouraging more individuals to consider treatment for bothersome menopausal symptoms and improve their quality of life.
