The U.S. Food and Drug Administration (FDA) approved new labels Friday for three estradiol patch products used in menopause hormone therapy, revising their boxed-warning sections.
The revised labels remove statements about cardiovascular disease, breast cancer and probable dementia from the boxed-warning section; cardiovascular disease and breast cancer warnings remain elsewhere in the prescribing information. The changes follow similar revisions for six hormone therapy products in February, bringing the total to nine, according to the U.S. Department of Health and Human Services (HHS). HHS said the decisions followed another review of scientific literature and are intended to align labeling with current science.
Demand for estradiol patches increased after February’s label changes, HHS said. Manufacturers’ combined patch production is now twice what it was a year earlier, and the FDA is working with all six manufacturers on supply, the department said. HHS acknowledged local access problems but said it was not aware of an imminent nationwide shortage. The Guardian reported that some patients continued to encounter stock-outs.
The FDA did not convene an advisory committee for the latest label changes, The Guardian reported. At a press briefing, officials said evidence supporting the revisions could be provided later, the newspaper reported.
Reshma Ramachandran, an assistant professor and health services researcher at Yale School of Medicine, told The Guardian that patients with histories of hormone-sensitive cancers need clear risk information. She warned that broad label changes could make potential harms less visible.
The Guardian also reported that the FDA did not convene advisory committees when it announced a wider label review in November 2025. By Oct. 30, 29 companies had proposed changes to hormone therapy labels, HHS said, and the agency is continuing to review those submissions.
The FDA is also exploring whether vaginal estrogen products could be sold over the counter. A switch to nonprescription sales would still need FDA approval.
