The US Food and Drug Administration (FDA) announced on Friday that it is removing black-box warnings from three additional estrogen patches used to treat menopause. The agency stated the move aims to address ongoing supply shortages, but the decision has drawn sharp criticism from medical experts who cite a lack of transparency and scientific justification.
The black-box warnings previously highlighted potential risks of cardiovascular disease, breast cancer, and dementia. The FDA did not convene an advisory committee to review the evidence before making the change. Officials offered few details on the scientific basis for the decision during a press briefing, stating that supporting evidence could be provided at a later date.
Supply Shortages Drive Label Changes
The removal of these warnings follows a similar action in February, when the FDA removed black-box warnings from six other menopause treatments. At that time, patients across the United States reported significant difficulties accessing their usual hormone therapies.
Sarah Ibrahim, deputy center director for regulatory programs at the FDA’s Center for Drug Evaluation and Research, acknowledged the frustration patients have faced. She noted that demand for estradiol patches increased significantly after the label changes in February, leading to stockouts at many pharmacies.
“We hear you,” Ibrahim said. “We are working with manufacturers to strengthen supply and improve access.” She added that manufacturing of estrogen patches has doubled over the past year. The agency is also working to change the labels of the remaining menopause hormone treatment (MHT) products.
Critics Question Transparency and Safety
Despite the agency’s focus on supply, some experts argue that the blanket removal of warnings about breast cancer and cardiovascular disease is misleading. Reshma Ramachandran, an assistant professor and health services researcher at Yale School of Medicine, expressed concern about the lack of clear justification for the decision.
“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. She noted that certain groups, such as those with histories of hormone-sensitive cancers, face particular risks.
The FDA defended the change by arguing that the previous warnings painted an overstated picture of risk. Ibrahim stated that updated evidence shows the risk-benefit profile is meaningfully 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 passing through the liver first, though risks increase with high doses.
However, critics point to a troubling precedent in how the FDA reached this conclusion. Last November, the agency bypassed its advisory committees, with a spokesperson describing them as bureaucratic, long, often conflicted, and expensive. Instead, the FDA convened a panel in July 2025 featuring doctors and influencers who were vocal proponents of MHT. Several panel members had conflicts of interest with practices that market and sell hormone therapy.
Ramachandran noted that the expert meeting did not allow for public testimony, including from the lead investigator of the Women’s Health Initiative, whose research originally formed the recommendations for MHT. After audience members voiced concern, the FDA opened a docket for public comment.
Menopause experts have also criticized sweeping claims about the benefits of MHT, including improvements in longevity, which they say are not supported by research. While there are benefits to the treatments for some women, the decision not to convene advisers or include broader research sets a concerning standard, they said.
In addition to the patch label changes, the FDA is exploring the possibility of offering vaginal estrogen products over the counter, according to an agency press release on Friday.
Source: The Guardian
