By Basant El-Faramawy
The U.S. Food and Drug Administration (FDA) announced Friday that three additional estrogen patches used to treat menopause symptoms will no longer carry black-box warnings about cardiovascular disease, breast cancer, and dementia. The decision follows the removal of similar warnings from six menopause treatments in February, amid ongoing shortages of the patches across the country.
Decision Made Without Advisory Committee
The FDA did not convene an advisory committee before making the change and provided few details on the scientific basis during a press briefing. When journalists requested the supporting evidence, officials said it could be supplied later.
Experts Raise Transparency Concerns
Reshma Ramachandran, an assistant professor and health services researcher at Yale School of Medicine, criticized the lack of transparency. She said the blanket removal of warnings without clear justification could mislead patients and underplay potential harms, particularly for those with histories of hormone-sensitive cancers.
Shortages Drive Demand
Officials highlighted the supply shortages patients have faced. Dorothy Fink, deputy director of the National Institute of Child Health and Human Development, said manufacturing of estrogen patches has doubled over the past year, yet stock-outs persist. Sarah Ibrahim, deputy center director for regulatory programs at the FDA’s Center for Drug Evaluation and Research, acknowledged frustration and said demand increased significantly after the February label changes.
FDA Defends Decision Based on Updated Evidence
Ibrahim stated that the black-box warnings painted a broad and sometimes overstated picture of risk. She said updated evidence shows that for many healthy women under 60 and within 10 years of menopause onset, the risk-benefit profile differs meaningfully from older warnings. Estradiol patches are generally considered lower risk than synthetic oral medications because they bypass the liver, though risks increase with high doses.
Political Context and Ongoing Debate
Menopause experts have noted that officials in the Trump administration made sweeping, data-free claims about the benefits of menopause hormone therapy, including improvements in longevity, which are not supported by research. While the treatments offer benefits for some women, critics say the decision to forgo advisory committees and transparent evidence review sets a troubling precedent.
Previous Bypass of Advisory Panels
The FDA also bypassed its advisory committees in November when it first announced the warning removals, citing bureaucratic and cost concerns. In July 2025, the agency convened a panel of doctors and influencers who were vocal proponents of menopause hormone therapy, several with conflicts of interest, according to Ramachandran. Public testimony was not allowed at that meeting.
Over-the-Counter Vaginal Estrogen Considered
The FDA is also exploring the possibility of offering vaginal estrogen products over the counter, according to a Friday press release.
