US health department to remove broad black box warning from three estrogen patch products
XLV•The US health department approved removing the strictest “black box” warnings from three estradiol patch labels. Estrogen patch market output has doubled over the past year, and manufacturers continue to expand capacity, a health department official said.
1. Warnings removed
The US Department of Health and Human Services approved removing the strictest “black box” warnings from labels of three estradiol transdermal patches used to treat menopause symptoms. The department did not immediately provide the patches’ brand names.
2. Supply and reviews
The FDA has been working with manufacturers since September to boost estrogen patch supplies, though it has not designated the patches as being in shortage. Deputy director Dorothy Fink said patch market output had doubled over the past year and manufacturers continued to expand capacity. The FDA said it was working on labeling changes for the remaining menopausal hormone therapy products and had expedited review of 10 manufacturer requests this year to date.
