By Fatma Younis
The U.S. Department of Health and Human Services has approved the removal of the most stringent "black box" warnings from the packaging of three estradiol transdermal patches used to treat menopausal symptoms. The move comes as American women continue to face difficulties obtaining hormone replacement therapies such as estrogen patches amid a sharp rise in demand.
FDA Action Follows Earlier Revisions
The decision follows February revisions when the Food and Drug Administration authorized the removal of warnings regarding breast cancer, cardiovascular disease, and probable dementia from six menopausal hormone therapy products. The department did not immediately disclose the specific brand names of the updated patches.
Supply Efforts Underway
While the FDA has been engaging with manufacturers since September to boost patch supplies, the agency has not officially designated the products as being in shortage. Dorothy Fink, deputy director of the National Institute of Child Health and Human Development, said estrogen patch market output has doubled over the past year and manufacturers continue to expand capacity.
Expedited Label Modifications
Sarah Ibrahim, deputy center director for regulatory programs at the FDA's Center for Drug Evaluation and Research, said the agency has expedited the review and approval of 10 supplements this year to date, with two approved in the past week alone. These supplements are requests from manufacturers to make changes that could expand production. Scarcities have also previously affected certain vaginal and injectable estrogen options.
