WASHINGTON, D.C. – The Food and Drug Administration announced Monday it is removing prominent black box safety warnings from hormone therapy treatments prescribed for menopause and perimenopause symptoms, marking a significant shift in how the agency views these medications.
The warnings, which appeared on creams, pills, and other formulations, cautioned that hormone therapies could elevate risks for certain cancers, dementia, heart attacks, and strokes. The FDA said those warnings discouraged women from using medications that could actually benefit their health.
FDA Commissioner Marty Makary explained the decision, telling CBS News that “we now have a more nuanced understanding, and we want to put that fear machine in its proper context and let people know that there are tremendous long-term health benefits.”
The agency cited recent studies demonstrating that hormone therapies can reduce risks of Alzheimer’s disease, heart attacks, and hip fractures. An analysis of 30 studies conducted between 1966 and 2003 suggested that starting hormone replacement therapy earlier in a woman’s life could save lives.
The FDA convened an expert panel in July to review the evidence and received nearly 3,000 public comments by late September before making its decision.
However, the abbreviated review process has drawn criticism from some medical organizations. The American College of Obstetrics and Gynecology questioned whether the process had the rigor of a standard advisory committee meeting.
The organization called for separate meetings to evaluate low-dose vaginal estrogen versus systemic hormone therapy, arguing that different formulations carry different risk profiles and should be assessed independently.
Hormone therapy remains one of the most effective treatments for managing menopause symptoms including hot flashes, night sweats, and vaginal dryness. The treatments can also help prevent bone loss that leads to osteoporosis.
The decision affects millions of American women who experience menopause symptoms, typically between ages 45 and 55, though symptoms can begin earlier or last for years after menopause.
Makary emphasized that the decision reflects evolving scientific understanding and aims to ensure women and their doctors can make informed decisions without being deterred by outdated warnings.
