The US Food and Drug Administration has stripped black-box warnings from three additional estrogen patches treating menopause symptoms, citing updated evidence about cardiovascular disease, breast cancer, and dementia risks. The decision, announced on Friday, marks the second wave of such removals in less than nine months and has drawn criticism from medical experts over the agency's lack of transparency and bypass of its standard advisory committee process.
According to The Guardian, the FDA did not convene an advisory committee and provided minimal scientific justification during its press briefing. This follows the removal of black-box warnings from six menopause treatments in February, a period when patients across the United States have struggled with severe shortages of the patches.
Reshma Ramachandran, an assistant professor and health services researcher at Yale School of Medicine, expressed alarm at the decision-making process.
"I have been concerned by the lack of transparency behind these decisions,"she said.
"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."
Why are patients facing shortages?
Supply disruptions have created urgent demand for menopause hormone treatments across the country. Dorothy Fink, deputy director of the National Institute of Child and Human Development, stated that manufacturing of estrogen patches has doubled over the past year as the agency works with manufacturers to strengthen supply and improve access.
Sarah Ibrahim, deputy center director for regulatory programs of the FDA's Center for Drug Evaluation and Research, acknowledged the frustration patients have experienced.
"We know that for some patients, these past months have been frustrating,"she said.
"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."The FDA continues working with manufacturers to increase production and is revising labels for remaining hormone therapy products.
The supply crisis has been particularly acute in the United Kingdom as well. Women facing HRT medication shortages have been urged to consult their GP or pharmacist for guidance on alternatives, with disruptions affecting specific patch brands expected to persist through late 2026.
What is the scientific basis for removing the warnings?
The FDA argues that the black-box warnings
"painted a broad and, in some cases, overstated pictures of risk."Ibrahim stated that
"updated evidence shows that for many healthy women under 60 and within 10 years of menopause onset, the risk-benefit profile looks meaningfully different than older warnings conveyed."
However, the agency's characterization of the evidence differs from how the warnings are actually structured. According to the FDA's consumer guidance, cardiovascular and breast-cancer risks remain in the "Warnings and Precautions" section of product labeling; the requested changes remove those statements from the boxed warning only, not from labeling altogether. Additionally, the FDA's requested label changes also remove the recommendation to use the lowest effective dose for the shortest duration, though systemic estrogen-only products retain a boxed warning about endometrial cancer.
Estradiol patches are generally considered safer than synthetic oral medications because they enter the bloodstream without first passing through the liver, reducing certain metabolic risks. However, the risks associated with patches increase with higher doses.
Who raised concerns about the decision-making process?
Ramachandran emphasized that certain patient populations face particular risks. Those with histories of hormone-sensitive cancers require individualized assessment rather than blanket policy changes, she argued. She also highlighted concerns about how the FDA conducted its review process.
The FDA bypassed its advisory committees in November 2025 when it first announced plans to remove the warnings. At that time, a spokesperson told The Guardian that committees are
"bureaucratic, long, often conflicted, and very expensive."Instead of a traditional advisory committee, the FDA convened a meeting in July 2025 featuring doctors and influencers, all of whom were vocal proponents of hormone therapy and several of whom had conflicts of interest with practices that market and sell hormone therapy, according to Ramachandran.
"At the expert meeting, they also did not allow for public testimony,"Ramachandran said. This restriction prevented input from the lead investigator of the Women's Health Initiative, whose research formed the basis for the original menopause hormone therapy recommendations and who was present in the audience. Following audience members' concerns, the FDA opened a docket for public comment.
What do menopause experts say about the broader implications?
Officials in the Trump administration have made sweeping claims about the benefits of hormone therapy, including improvements in longevity, which lack research support, according to menopause experts. While treatments do provide genuine benefits for some women, the decision to bypass advisers and exclude comprehensive research has set what experts describe as a troubling precedent for future regulatory decisions.
The original black-box warnings were introduced in 2003 following the Women's Health Initiative trials, which studied systemic hormones for prevention of coronary heart disease in postmenopausal women. Those findings prompted decades of cautious prescribing guidance.
What regulatory changes are coming next?
The FDA is pursuing multiple pathways to expand access to hormone therapies. The agency is exploring the possibility of offering vaginal estrogen products over the counter, which would eliminate the need for prescriptions for those formulations.
On the manufacturing front, the FDA approved the first generic once-weekly Climara Pro patch, containing estradiol and levonorgestrel, on October 20, 2026, potentially expanding treatment options and reducing costs for patients. The FDA has indicated that additional companies may submit label changes, with its request covering estrogen- or progestogen-containing therapies across multiple dose forms.
