Key facts
- US health department removed "black box" warnings from three estradiol transdermal patches.
- The patches are used to treat menopause symptoms.
- The action follows similar label changes for six other menopause treatments in February.
- FDA officials cited updated evidence suggesting a different risk-benefit profile for many healthy women under 60.
- The agency is working with manufacturers to increase supply amid patient shortages.
The US health department on Friday approved removing strict "black box" warnings from three estradiol transdermal patches, hormone therapies used to treat menopause symptoms. The action adds to labeling changes for six menopausal hormone therapy products approved in February to remove warnings related to cardiovascular disease, breast cancer, and probable dementia.
Officials at the US Food and Drug Administration (FDA) said the decision was made without convening an advisory committee, offering few details on the scientific basis. The FDA is working with manufacturers to boost supplies of estrogen patches, which have faced shortages. Dorothy Fink, deputy director of the National Institute of Child Health and Human Development, said that estrogen patch market output has doubled over the past year and manufacturers continue to expand capacity.
Sarah Ibrahim, deputy center director for regulatory programs at FDA's Center for Drug Evaluation and Research, stated that updated evidence shows a different risk-benefit profile for many healthy women under 60 and within 10 years of menopause onset. The FDA is also exploring the possibility of offering vaginal estrogen products over the counter.