FDA campus entrance sign and Building 21, Silver Spring, Maryland, November 2010. Archive photo: U.S. Food and Drug Administration / Wikimedia Commons. Public domain. Cropped.
The Food and Drug Administration approved updated warning labels for three more menopause hormone-therapy patches Friday, while reporting that estradiol-patch output has doubled over the past year as manufacturers respond to rising demand.
The changes remove statements about cardiovascular disease, breast cancer and probable dementia from the boxed-warning sections of three additional estradiol transdermal patch products, according to an October 30 announcement from the Department of Health and Human Services.
The action extends labeling changes approved for six menopause hormone-therapy products in February. It is not the approval of a new treatment, and the announcement does not mean hormone therapy is risk-free or suitable for every patient.
More patches, but local access problems remain
FDA said all six manufacturers of approved estradiol patches have been working to expand production through additional capacity, extra manufacturing shifts and prioritizing patch output. Those efforts have doubled overall market output in the last 12 months, the agency said.
Based on its current information, FDA said it was not aware of an imminent risk of a nationwide shortage of approved menopause hormone therapies. It nevertheless acknowledged patients’ reports of local difficulty finding their usual products.
Availability can differ by brand, strength, once-weekly or twice-weekly formulation, and location. The agency advised patients having trouble finding their usual patch to speak with a pharmacist or healthcare provider about an appropriate available alternative.
Nonprescription estrogen remains under study
FDA also said it was working with sponsors to explore potential over-the-counter availability of vaginal estrogen products. No such switch was approved in Friday’s announcement.
Any move from prescription to nonprescription status would require FDA approval and evidence that consumers can choose and use a product safely and effectively without a healthcare professional’s supervision, HHS said.
The agency said 29 drug companies have submitted proposed menopause hormone-therapy labeling changes since it began asking manufacturers for revisions in November 2025. HHS said Friday’s patch-label changes followed a re-examination of scientific literature and updated benefit-risk information.
The announcement did not identify the three patch products or their two applicants by name. Decisions about treatment remain individual decisions for patients and their healthcare professionals.
JBizNews Desk | WASHINGTON
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