A panel of doctors has urged the FDA to remove black box warning labels from low-dose estrogen treatments, citing that they are not supported by science and may be deterring women from using beneficial medication. The label warnings, which include increased risks of endometrial cancer, cardiovascular disorders, probable dementia, and breast cancer, have been in place since 2002 but researchers have since determined the cancer risk was overstated.
The panel, convened by FDA Commissioner Dr. Marty Makary, included obstetricians and women’s health experts who argued that the warnings are unnecessary for low-dose vaginal estrogen treatments, which carry a lower cancer risk. They also pointed out that these medications can alleviate symptoms such as frequent urinary tract infections, vaginal dryness, and pain during sexual intercourse.
However, Dr. Adriane Fugh-Berman, a professor of pharmacology at Georgetown University, expressed skepticism about removing the labels, citing concerns about the FDA’s decision-making process. She noted that the agency typically follows a rigorous evaluation process before making changes to medication warnings.
Despite these concerns, the panel’s push for change signals a shift in the medical establishment’s stance on hormone replacement therapies for menopause. Dr. Marty Makary acknowledged that 50 million women have not been offered the benefits of hormone replacement therapy due to “medical dogma.” The FDA may consider revising its guidelines and labeling requirements for these medications, potentially paving the way for more women to access beneficial treatments.
Source: https://www.npr.org/sections/shots-health-news/2025/07/25/nx-s1-5477644/menopause-hormone-therapy-fda-health