FDA sidesteps advisers again as it drops black-box menopause drug warnings

Health experts have raised fresh concerns about a lack of transparency after the US Food and Drug Administration removed black-box warnings from three estrogen patches used to treat menopause.

Officials said on Friday that the patches would no longer carry warnings about cardiovascular disease, breast cancer and dementia. The move follows the agency’s earlier removal of black-box warnings from six menopause treatments, as patients across the US face shortages of the patches.

When reporters asked for the evidence supporting the decision, officials said it would be provided later.

Reshma Ramachandran, an assistant professor and health services researcher at Yale School of Medicine, said she was troubled by the absence 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 added that some patients, including those with a history of hormone-sensitive cancers, face particular risks.

Instead of focusing on those concerns, officials pointed to shortages in menopause hormone treatments. Dorothy Fink, deputy director of the National Institute of Child Health and Human Development, said the agency was working with manufacturers to improve supply and access, and noted that production of estrogen patches had doubled over the past year.

Even so, patients continue to report stock-outs.

Sarah Ibrahim, deputy center director for regulatory programs at the FDA’s Center for Drug Evaluation and Research, said many patients have been frustrated in recent months. After the label changes earlier in the year, she said, demand for estradiol patches rose sharply and many people could not find their usual product at their regular pharmacy.

“And I want you to know that we hear you,” Ibrahim said. She also said the agency is working with manufacturers to increase production and is moving ahead with label changes for the remaining menopause hormone therapy products.

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

Estradiol patches are generally considered lower risk than synthetic oral medications because they enter the bloodstream without first passing through the liver. Research shows the risks rise with higher doses.

Some menopause specialists have accused officials in the Trump administration of making sweeping claims about the benefits of menopause hormone therapy, including assertions about longer life, that are not backed by evidence. They argue that although the treatments can help some women, bypassing advisers and setting aside research creates a troubling precedent.

The FDA also bypassed its advisory committees last November when it said it would remove the warnings. At the time, a spokesperson described those committees as “bureaucratic, long, often conflicted, and very expensive”.

Instead, the agency held a panel in July 2025 made up of doctors and influencers who strongly supported menopause hormone therapy, several of whom had conflicts of interest with businesses that market and sell hormone treatments, Ramachandran said.

“At the expert meeting, they also did not allow for public testimony,” Ramachandran said, adding that this included the lead investigator of the Women’s Health Initiative, whose research shaped the recommendations for menopause hormone therapy, even though that person was in the audience. After attendees objected, the FDA opened a docket for public comment.

The agency is also considering whether vaginal estrogen products should be available over the counter, according to a press release issued on Friday.