FDA removes black-box warnings from three more menopause patches

The U.S. Food and Drug Administration on Friday lifted the boxed warnings on cardiovascular disease, breast cancer, and dementia from three additional menopause patches, according to the Guardian. The agency decided without convening an advisory committee and provided few specifics on the scientific basis at a press briefing.

The action follows the February removal of the same warnings from six menopause therapies, while patients across the country report shortages of the patches. When asked for the evidence behind the decision, FDA officials said it could be provided later.

Yale School of Medicine health services researcher Reshma Ramachandran said she is concerned by the lack of transparency. “The blanket removal of black-box warnings regarding risks of breast cancer and cardiovascular disease without clear justification can be misleading for patients and underplays real potential harms,” she said. She noted particular risks for patients with histories of hormone-sensitive cancers.

FDA officials instead highlighted supply problems for menopause hormone treatments. Dorothy Fink, a deputy director at the National Institute of Child Health and Human Development, said the agency is working with manufacturers to strengthen supply and improve access. Output of estrogen patches has doubled over the past year, she said. Patients still report stock-outs of the patches.

Sarah Ibrahim, deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said that after the February label changes, demand for estradiol patches “increased significantly, and patients in many areas found it difficult to get their usual patches at their usual pharmacy”. She added that the agency is working with manufacturers to ramp up production and to change the labels of the remaining menopause hormone therapy products.

Ibrahim said the black-box warnings “painted a broad and, in some cases, overstated pictures of risk,” and that updated evidence shows the risk-benefit profile is substantially different for many healthy women under 60 who are within 10 years of menopause onset.

Estradiol patches generally carry less risk than oral synthetic hormones, since they reach the bloodstream without passing through the liver first. Research shows that risks from the patches are higher with high doses.

Menopause experts have said that officials in the Trump administration made sweeping “data-free” claims about benefits of menopause hormone therapy, including assertions about longer life that are not backed by research. They said the agency's decision to skip advisers and omit research sets a troubling precedent.

The FDA bypassed its advisory committees last November when it announced it would remove the warnings; a spokesperson said at the time that committees are “bureaucratic, long, often conflicted, and very expensive”. Instead, the agency convened a panel in July 2025 featuring doctors and influencers who were all vocal proponents of menopause hormone therapy, several of whom had financial ties to practices that market and sell hormone therapy, according to Ramachandran. At that meeting, the FDA did not allow public testimony, among them the lead investigator of the Women’s Health Initiative, who was seated in the audience, she said. After audience members raised objections, the FDA opened a docket for public input.

The agency is also considering making vaginal estrogen products available without a prescription, according to an agency press release on Friday.