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. Instead, officials highlighted the shortages patients are facing for menopause hormone treatments (MHT). Manufacturing of estrogen patches has doubled over the past year, she said.
Even so, patients report stock-outs of the patches. 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. The black-box warnings “painted a broad and, in some cases, overstated pictures of risk”, she said.
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 2025 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. 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.
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