11/11/2025
On November 10, 2025 the FDA removed the “black box” warning from systemic estrogen therapy in menopause after decades of outdated data. Why this matters: the warning caused many women to avoid hormone replacement therapy (HRT) out of fear, despite more recent evidence showing benefits when started appropriately. Research now shows that for many women under age 60 or within 10 years of menopause, HRT may have more benefit than risk. What this means for you: If you’re dealing with menopause symptoms (hot flashes, sleep disruption, mood changes) or want to proactively maintain metabolic and cardiovascular, health, you now have better access to a key tool. This is a huge win for menopause care and for most women who will live 30 - 40% of their lives post-menopause.
The Food and Drug Administration will remove the "black box" warning from hormone replacement therapy (HRT) products for menopause.
