FDA wants vaginal estrogen available over the counter for menopause

Key Points:

• The FDA is considering making some types of vaginal estrogen available over the counter by mid-2027, aiming to improve access to this hormone treatment for menopausal women and reduce life-threatening urinary tract infections (UTIs).
• Vaginal estrogen has been shown to cut the risk of UTIs in menopausal women by more than half, which is critical as UTIs can lead to sepsis and death in older women due to estrogen-related tissue changes.
• The FDA removed longstanding warning labels on estrogen products in 2025-2026 that had discouraged use, following evidence that these warnings were based on misinterpretations and hindered treatment for menopause-related health issues.
• Medical experts and associations advocate for increased education and access to vaginal estrogen, emphasizing that recurrent UTIs should not be accepted as inevitable with aging and that better physician awareness is needed.
• Despite its benefits, vaginal estrogen remains underused, with only about 10% of Medicare-covered menopausal women using it; efforts to increase supply, insurance coverage, and physician alerts are underway to boost its adoption.