Home / Health / FDA Lifts Warnings on Menopause Hormone Therapy, Expanding Treatment Options
FDA Lifts Warnings on Menopause Hormone Therapy, Expanding Treatment Options
10 Nov
Summary
- FDA removes "black box" warnings on hormone replacement therapy for menopause
- Over 20 estrogen-related products no longer carry warnings on cardiovascular disease, breast cancer, and dementia
- FDA approves new drugs to expand treatment options for menopausal symptoms
On November 10, 2025, the U.S. Food and Drug Administration announced a significant change in its approach to hormone replacement therapy (HRT) for menopausal women. Health and Human Services Secretary Robert F. Kennedy Jr. stated that the agency would be removing the "broad black box" warnings from over 20 estrogen-related products used to treat hot flashes and other menopausal symptoms.
This decision comes after an expert literature review conducted in July 2025, which involved doctors and researchers who supported the health benefits of HRT. The FDA is now working with drugmakers to update and reprint the labels, signaling a shift towards "evidence-based medicine" and giving women more control over their health.
In addition to the label changes, the FDA has also approved two new drugs to expand treatment options for menopausal symptoms. This includes a generic version of Premarin and a non-hormonal medication to address hot flashes and other symptoms related to blood vessel changes.
The move has been welcomed by the American College of Obstetricians & Gynecologists, who have called the modifications to certain warning labels "years in the making." They believe this will allow patients and clinicians to engage in a shared decision-making process without unnecessary barriers when it comes to managing menopausal symptoms.
