FDA again removes black-box warnings from three more menopause patches

Experts fault lack of transparency as FDA bypasses advisory committee

Three more patches for treating menopause will no longer carry black-box warnings about cardiovascular disease, breast cancer and dementia, officials at the US Food and Drug Administration said on Friday. The agency did not convene an advisory committee for the decision and offered few details on the scientific basis for it during a press briefing.

The move follows the FDA’s removal of black-box warnings from six menopause treatments in February, a change that came as patients across the United States struggle with shortages of the patches. When journalists asked for the evidence behind Friday’s decision, officials said it could be provided later.

“I have been concerned by the lack of transparency behind these decisions,” said Reshma Ramachandran, an assistant professor and health services researcher at Yale School of Medicine. “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.”

Ramachandran said there are particular risks for certain groups of patients, such as those with histories of hormone-sensitive cancers. Officials instead highlighted the shortages patients are facing for menopause hormone treatments (MHT).

“We are working with manufacturers to strengthen supply and improve access,” said Dorothy Fink, deputy director of the National Institute of Child Health and Human Development. Manufacturing of estrogen patches has doubled over the past year, she said. Even so, patients report stock-outs of the patches.

“We know that for some patients, these past months have been frustrating,” said Sarah Ibrahim, deputy center director for regulatory programs of the FDA’s Center for Drug Evaluation and Research. Demand for estradiol patches “increased significantly, and patients in many areas found it difficult to get their usual patches at their usual pharmacy” after February’s label change, she said. “And I want you to know that we hear you.”

The FDA is working with manufacturers to ramp up production, Ibrahim said, and the agency is also working to change the labels of the remaining MHT products.

The black-box warnings “painted a broad and, in some cases, overstated pictures 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 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. Research shows the risks of the patches are higher with high doses.

Officials in the Trump administration have made sweeping and “data-free” claims about the benefits of MHT, including improvements in longevity that are not supported by research, menopause experts have said. While there are benefits to the treatments for some women, the experts said, the decision not to convene advisers or include 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 the committees are “bureaucratic, long, often conflicted, and very expensive”.

Instead, the agency convened a panel in July 2025. Ramachandran said that panel featured doctors and influencers who were all vocal proponents of MHT, and that several of the participants had conflicts of interest with practices that market and sell hormone therapy.

“At the expert meeting, they also did not allow for public testimony,” Ramachandran said. That included testimony from the lead investigator of the Women’s Health Initiative, the research that formed the recommendations for MHT, who was in the audience. After audience members voiced concern, the FDA opened a docket for public comment.

The FDA is also exploring the possibility of offering vaginal estrogen products over the counter, according to an agency press release issued Friday.