12/31/2025
As of November 2025, the "black box warning" on hormone therapy (HRT) is being removed by the FDA. Recent data and research show that the benefits often outweigh risks for healthy women under 60 starting HRT. A warning remains for endometrial cancer regarding estrogen-only products for women with a uterus.
This change aims to encourage appropriate use of HRT for symptoms like hot flashes, bone protection, and potentially heart health, but speak with your doctor, especially those with cancer history of estrogen-sensitive cancers (like breast cancer) as HRT is generally not recommended.
What Was the Black Box Warning?
• It was the FDA's strongest warning, added in 2003 after the Women's Health Initiative (WHI) study, highlighting risks of breast cancer, cardiovascular disease (stroke, heart attack), and dementia.
• This warning deterred many women from HRT, despite the study's limitations (mostly older women, older formulations).
Why is it Being Removed?
Updated Science:
Newer research shows that for many healthy women starting HRT near menopause, benefits often outweigh risks, particularly for short-term symptom relief and long-term bone/heart health.
Correcting Misinformation:
The FDA and HHS state the original warning led to "bad science and bureaucratic inertia," causing millions to miss out on effective treatment.
The risk-to-benefit ratio is different for younger women (under 60/within 10 years of menopause) versus older women, and for different hormone types (estrogen-only vs. estrogen + progestin).
Talk to your doctor. Have a discussion about your menopause symptoms, overall health, and personal risk factors and benefits of HRT.
