Menopause patch black box warnings removed as American women face treatment shortages

The United States Department of Health has sanctioned the removal of the most stringent “black box” warnings from the packaging of three estradiol transdermal patches used for menopausal treatment.

American women face ongoing difficulties sourcing hormone replacement options like estrogen patches to address symptoms such as hot flashes, mood swings, and disrupted sleep amid a sharp rise in demand.

The Department of Health and Human Services did not immediately respond to requests seeking the specific brand names of the updated patches.

The decision follows earlier revisions in February, when the FDA authorized the removal of warnings regarding breast cancer, cardiovascular disease, and probable dementia from six menopausal hormone therapy items.

While the US Food and Drug Administration has been engaging with producers since September to bolster patch supplies, the agency has not officially designated them as being in a shortage.

“Estrogen patch market output has doubled over the past year, and manufacturers continue to expand capacity,” stated Dorothy Fink, deputy director of the National Institute of Child Health and Human Development, during a briefing.

The agency is working quickly to address label modifications for additional menopausal hormone therapies.

“FDA has expedited the review and approval of 10 supplements this year to date, which are requests from manufacturers to make changes that could expand production. Two of these requests were approved within the past week alone,” said Sarah Ibrahim, deputy center director for regulatory programs at FDA’s Center for Drug Evaluation and Research.

Scarcities have also previously impacted certain vaginal and injectable estrogen options.