FDA again bypasses advisors to remove black box warnings from menopause treatments | Healthcare in the United States

Three more patches intended to treat menopause will no longer carry warnings about cardiovascular disease, breast cancer and dementia, U.S. Food and Drug Administration (FDA) officials announced Friday.

The FDA did not convene an advisory committee and provided few details about the scientific basis for the decision during the press briefing. The news follows the removal of black box warnings for six menopause treatments in February, as patients across the United States battle patch shortages.

When reporters asked for evidence of the decision, officials said it could be provided later.

“I have been concerned about the lack of transparency behind these decisions,” said Reshma Ramachandran, an assistant professor and health services researcher at the Yale School of Medicine. “Total removal of black box warnings about breast cancer and cardiovascular disease risks, without clear justification, may be misleading to patients and underestimates the actual potential harms. »

There are particular risks for certain groups of patients, such as those with a history of hormone-sensitive cancers, she said. Instead, officials highlighted the shortages patients face when it comes to menopausal 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 in the past year, she said.

Despite this, patients are reporting stock shortages of patches.

“We know that for some patients, these last few months have been frustrating,” said Sarah Ibrahim, deputy director for regulatory programs at the FDA’s Center for Drug Evaluation and Research. After the label change in February, demand for estradiol patches “increased significantly and patients in many areas had difficulty obtaining their usual patches at their regular pharmacy,” she said. “And I want you to know that we hear you.”

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

Black box warnings “paint a broad and, in some cases, exaggerated picture of risk,” she said. “Updated evidence shows that for many healthy women under the age of 60 and within 10 years of the onset of menopause, the risk-benefit profile appears significantly different from older warnings.”

Estradiol patches are generally considered lower risk than synthetic oral medications because they pass into the bloodstream without first passing through the liver. Patch risks are higher at higher doses, research shows.

Trump administration officials have made sweeping, “data-free” claims about MHT’s benefits, including improvements in longevity, that are not supported by research, menopause experts said. Even if the treatments have benefits for some women, the decision not to assemble counselors or include research sets a troubling precedent, they said.

The FDA bypassed its advisory committees last November by announcing it would remove the warnings; at the time, a spokesperson said the reason was that the committees were “bureaucratic, time-consuming, often conflicting and very expensive”.

Instead, the FDA convened a panel in July 2025 consisting of doctors and influencers, all of whom were strong supporters of MHT and several of whom had conflicts of interest with firms that market and sell hormone therapies, Ramachandran said.

“At the expert meeting, they also did not allow public testimony,” Ramachandran said – including from the principal investigator of the Women’s Health Initiative, whose research formed the recommendations for MHT, who was present in the audience. After audience members expressed their concerns, the FDA opened a public comment docket.

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