11/21/2025
Big news for women’s health: the FDA has officially removed the black box warning from many hormone therapy products—a label that’s been in place for over 20 years.
For decades, this warning created confusion and fear, often preventing women from finding relief from menopausal symptoms like hot flashes, night sweats, sleep disruption, and mood changes. But recent research shows the original data—largely based on older women using older formulations—doesn’t reflect the risks for women starting therapy closer to menopause.
The updated FDA labeling now focuses on individual risk, timing, and formulation, giving women and their providers the ability to make more informed, personalized decisions. Estrogen-only therapy for women with a uterus will still carry an endometrial cancer warning, but overall this marks a shift toward more nuanced, evidence-based guidance.
This FDA update reinforces what we practice every day: data-driven, individualized hormone optimization as part of a complete longevity plan.
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