The Food and Drug Administration (FDA) has decided to lift the black box warnings on hormone therapy used to treat menopause symptoms. This change impacts creams, pills, and other treatments. Previously, these warnings suggested that such therapies might raise risks for certain cancers, dementia, heart attacks, and strokes. According to FDA Commissioner Marty Makary, these fears discouraged many women from using therapies that could actually benefit their health.
In July, the FDA had an expert panel review the potential risks and benefits of low-dose vaginal estrogen. The feedback was overwhelming, with nearly 3,000 public comments received by the September deadline. The American College of Obstetrics and Gynecology (ACOG) has been advocating for a reassessment of these warnings, emphasizing that low-dose vaginal estrogen is different from systemic estrogen found in pills and patches.
The shift comes after years of criticism over the messaging surrounding hormone therapy. A pivotal 2002 study known as the Women’s Health Initiative raised concerns about hormone therapy, linking it to increased risks. However, more recent studies suggested these risks may have been overstated. The therapy may even lower the risk of heart disease when taken early.
Despite the FDA’s move, some physicians criticized the process. ACOG argued that the brief nature of the July panel didn’t replace the thorough evaluation typically associated with FDA advisory committees. They felt that a detailed review is crucial for transparency, especially when discussing important health topics like menopause treatment.
Recent research supports the announcement. Studies indicate that hormone therapies can reduce the risk of Alzheimer’s, heart attacks, and hip fractures. For instance, an analysis spanning several decades showed that starting hormone replacement therapy early could be life-saving.
This decision is a significant step in reassessing how menopause therapies are viewed. As the conversation continues, many are hopeful for more supportive guidelines that emphasize the benefits of these treatments. You can read more about the specifics of the FDA’s findings and recommendations in trusted health resources like the National Institutes of Health and the American College of Obstetricians and Gynecologists.
