The FDA is considering removing the black box warning from low-dose vaginal estrogen products following a unanimous opinion from an expert advisory panel that risks have been overstated for years.
• Vaginal estrogen is a local, low-dose treatment that stays in the vagina with minimal systemic absorption
• The black box warning came from the 2002 Women's Health Initiative study that incorrectly applied systemic hormone risks to all estrogen products
• 72% of sepsis cases in older women could potentially be prevented with vaginal estrogen use
• Vaginal estrogen helps restore tissue elasticity, prevent UTIs, and protect the urethra
• Even women on systemic hormone therapy may need vaginal estrogen as the "vagina is her own little desert island"
• Application tip: use your finger to swirl the cream around rather than just using the applicator to prevent leakage
• Treatment regimen is typically twice weekly (like "Monday and Thursday vagina spa nights")
• Results may take up to three months to be fully noticeable
• Removing the warning could help more women access this beneficial treatment
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