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FDA Lifts Black Box Warning on Menopausal Hormone Therapy
10 Nov
Summary
- FDA to remove black box warning from hormone replacement products
- New labels to highlight long-term health benefits if started within 10 years of menopause
- Critics argue evidence for change is insufficient and could harm women's health
On November 10, 2025, the U.S. Food and Drug Administration (FDA) announced a radical shift in its stance on hormone replacement therapy (HRT) for menopausal women. The agency's commissioner, Dr. Marty Makary, stated that the long-term health benefits of HRT have been "largely misunderstood" and that it may improve women's health more than any other intervention, aside from antibiotics or vaccines.
As a result, the FDA will remove the so-called "black box" warning from all HRT products containing estrogen within the next six months. The new labels will provide age-specific guidance, indicating that there are significant long-term benefits if treatment is begun within 10 years of the onset of menopause.
However, this decision has faced criticism from some experts. Diana Zuckerman, a scientist and president of the National Center for Health Research, argued that "removing the black box and putting warnings in a lengthy label that many doctors and most patients will not read is taking women's health backward." She maintained that there are better ways to address conditions like osteoporosis, heart disease, cancer, and dementia than HRT.
The FDA's shift represents a dramatic turnaround from the agency's stance in the early 2000s, when large government-run clinical trials concluded that hormone pills did not protect against heart disease or dementia and actually increased the risk of blood clots and breast cancer. Since then, medical guidelines have advised women to use hormones only sparingly for menopausal symptoms.
