The Food and Drug Administration (FDA) has removed its boxed warning from more than twenty hormone-based therapies used to treat menopause symptoms, marking a major change in how the agency regulates these medications. The FDA’s update applies to products that deliver estrogen or estrogen-progestin combinations through pills, patches, gels, or sprays. The boxed warning, also known as a “black box” warning, is the FDA’s most serious caution, and has appeared on estrogen and combination hormone therapies since 2002.
In the 1990s, more than 1 in 4 women took estrogen either alone or in combination with progestin. The assumption was that it would reduce rates of heart disease and dementia in addition to treating menopause. The warning was added after the Women’s Health Initiative study linked hormone therapy to increased risks of heart attack, stroke, blood clots, and dementia. The average age of women in the study was 63, which is over a decade past the average age of a woman experiencing menopause at 52.
Dr. Steven Fleischman, President of the American College of Obstetricians and Gynecologists, noted that the warnings made patients hesitate to take the medication even when their condition was severe. This fear of potential risks to the fetus led to pregnant women to refuse necessary medical treatment, resulting in serious harm.
Agency officials said the change reflects new research showing that the risks seen in older women in the 2002 study do not apply equally to younger women, especially those under 60 or within 10 years of menopause. For those patients, the FDA said, hormone therapy remains an effective and generally safe option for easing hot flashes, night sweats, and other symptoms.
The boxed warning will be replaced with language advising patients and doctors to consider age, medical history, and timing when deciding on treatment. Other cautions will remain in place, including guidance that women with a uterus should use combined estrogen and progestin therapy to reduce the risk of uterine cancer.
This move reflects updated evidence and a more individualized approach to menopause care. FDA officials including Secretary Kennedy stated that “We are returning to evidence-based medicine and giving women control over their health again.”
The update comes amid growing attention to the lack of research and resources devoted to women’s care in the United States. Funding for women’s health research has lagged severely, with less than 9% of NIH grant spending between 2013 and 2023 focused exclusively on women’s health. More recently, the Trump administration has cut funding for research centering on women.
The FDA’s decision marks an important shift toward restoring trust in women’s medicine. By removing the blanket boxed warning, the agency acknowledges that menopause care requires individualized treatment rather than one-size-fits-all caution. This change could encourage more open conversations between patients and doctors, improve access to safe and effective therapies, and highlight the ongoing need for greater research and resources dedicated to women’s health.
