The U.S. health department approved removing black box warnings from three menopause patches
The U.S. health department 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 Reuters with the patches’ brand names. The action follows FDA-approved labeling changes in February for six menopausal hormone therapy products, removing warnings about cardiovascular disease, breast cancer and probable dementia.
More context
The U.S. health department approved removing the strictest “black box” warnings from the labels of three estradiol transdermal patches, hormone therapies used to treat menopause symptoms. The department did not immediately provide the patches’ brand names when Reuters asked.
The change follows FDA-approved labeling revisions in February for six menopausal hormone therapy products, which removed warnings related to cardiovascular disease, breast cancer and probable dementia. The FDA is working with applicants on labeling changes for the remaining menopausal hormone therapy products.
Women in the United States have struggled to find treatments such as estrogen patches amid surging demand. The FDA has worked with manufacturers since September to boost supplies, but has not designated the patches as being in shortage. Dorothy Fink, deputy director of the National Institute of Child Health and Human Development, said on a media call that estrogen patch market output has doubled over the past year and manufacturers continue to expand capacity.
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Reporting
- Reuters — US health department to remove broad black box warning ...
- journalrecord.com — FDA removes black box warnings from three estrogen patches
Verifier’s note
Reuters reports that the FDA approved removing black-box warnings from three estradiol patches used for menopause symptoms. Journal Record reports the same event using Reuters copy.