FDA again bypasses advisers to remove black-box warnings from menopause treatments

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 (FDA) said on Friday.

The FDA did not convene an advisory committee and offered few details on the scientific basis for the decision in the press briefing. The news follows the removal of black-box warnings from six menopause treatments in February, as patients across the US struggle with shortages of the patches.

When journalists asked for the evidence behind this 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.”

There are particular risks for certain groups of patients, such as those with histories of hormone-sensitive cancers, she said. Instead, officials 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. After the change to labels in February, demand for estradiol patches “increased significantly, and patients in many areas found it difficult to get their usual patches at their usual pharmacy”, she said. “And I want you to know that we hear you.”

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

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 ۶۰ and within ۱۰ 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. The risks of the patches are higher with high doses, research shows.

Officials in the Trump administration have made sweeping and “data-free” claims about the benefits of MHT, including improvements in longevity, which are not supported by research, menopause experts have said. While there are benefits to the treatments for some women, the decision not to convene advisers or include research sets a troubling precedent, they said.

The FDA bypassed its advisory committees last November in announcing it would remove the warnings; at the time, a spokesperson said that the reason is because committees are “bureaucratic, long, often conflicted, and very expensive”.

Instead, the FDA convened a panel in July ۲۰۲۵ featuring doctors and influencers, all of whom were vocal proponents of MHT and several of whom had conflicts of interest with practices that market and sell hormone therapy, Ramachandran said.

“At the expert meeting, they also did not allow for public testimony,” Ramachandran said – including from the lead investigator of the Women’s Health Initiative, research from which 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 on Friday.