FDA removes black-box warnings from three more menopause patches without adviser review

The change follows the removal of black-box warnings from six menopause treatments in February, and comes as patients across the US struggle with shortages of the patches. When journalists asked for the evidence behind the decision, officials said it could be provided later.

The decision drew criticism from Reshma Ramachandran, an assistant professor and health services researcher at Yale School of Medicine. "I have been concerned by the lack of transparency behind these decisions," she said. "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 pointed to particular risks for patients with histories of hormone-sensitive cancers.

Officials highlighted the shortages patients are facing. Dorothy Fink, deputy director of the National Institute of Child Health and Human Development, said: “We are working with manufacturers to strengthen supply and improve access.” Manufacturing of estrogen patches has doubled over the past year, she said. Sarah Ibrahim, deputy center director for regulatory programs at the FDA's Center for Drug Evaluation and Research, acknowledged the strain on patients. “We know that for some patients, these past months have been frustrating,” she said, adding that after the February label change, demand for estradiol patches “increased significantly, and patients in many areas found it difficult to get their usual patches at their usual pharmacy”. “And I want you to know that we hear you.”

Ibrahim said the black-box warnings "painted a broad and, in some cases, overstated pictures of risk". "Updated evidence shows that for many healthy women under 60 and within 10 years of menopause onset, the risk-benefit profile looks meaningfully different than older warnings conveyed."

Estradiol patches are usually considered lower risk than synthetic oral medications because they pass into the bloodstream without first going to the liver, although research shows the risks are higher with high doses. The FDA is also working to change the labels of the remaining menopause hormone therapy products, Ibrahim said, and is exploring whether vaginal estrogen products could be offered over the counter, according to an agency press release on Friday.

Menopause experts have said the decision not to convene advisers or include research sets a troubling precedent, and that officials in the Trump administration have made sweeping and "data-free" claims about the benefits of the treatments, including improvements in longevity that research does not support.

The FDA bypassed its advisory committees last November when it announced it would remove the warnings; at the time, a spokesperson said the committees are “bureaucratic, long, often conflicted, and very expensive”. Instead, the agency convened a panel in July 2025 of doctors and influencers, all vocal proponents of menopause hormone therapy and several with conflicts of interest with practices that market and sell it, Ramachandran said. Ramachandran said public testimony was not allowed at the meeting, including from the lead investigator of the Women's Health Initiative, whose research formed the recommendations for the therapy and who was in the audience. After audience members voiced concern, the FDA opened a docket for public comment.