11/26/2025
FDA Removes Black-Box Warning on HRT
Important update from the FDA: has removed the long-standing black-box warnings from many FDA-approved hormone replacement therapy (HRT) products for menopause. This change reflects current evidence and acknowledges the proven safety and benefits of appropriately prescribed hormone therapy.
As a provider that has specialized in bio-identical hormone replacement therapy, I have long advocated for women’s health and for access to individualized, natural hormone options. This FDA action validates what many of you have seen in practice—patients experience significant symptom relief and strong outcomes when therapy is tailored to their needs.
Key points from the FDA announcement:
Black-box warnings related to cardiovascular disease, breast cancer, and dementia are being removed.
The endometrial cancer warning remains only for systemic estrogen-alone therapy in women with a uterus.
Updated guidance encourages considering HRT within 10 years of menopause onset or before age 60.
If you’re suffering from perimenopause symptoms or menopause itself, I would love to help you through this journey. Call for a consultation at 775-204-0261