FDA again bypasses advisers to remove black-box warnings from menopause treatments
Some experts express concern about ‘lack of transparency’ as agency removes warnings on three estrogen patches Three more patches for treating menopause will no longer carry black-box warnings about cardiovascular disease, breast cancer, and dementia, officials at the US Food and Drug Administration (FDA) said on Friday. The FDA did not convene an advisory committee and offered few details on the…
The US Food and Drug Administration (FDA) has removed black-box warnings from three estrogen patches used to treat menopause, despite concerns from experts over a lack of transparency. These patches will no longer carry warnings about cardiovascular disease, breast cancer, and dementia. The FDA did not convene an advisory committee to discuss the decision and offered few details.
The news comes after the removal of black-box warnings from six menopause treatments in February, amid reports of shortages for patients. Reshma Ramachandran, a health services researcher at Yale School of Medicine, expressed concern over the sudden removal of warnings without clear justification, stating it could be misleading for patients.
The FDA cited ongoing supply issues, emphasizing that manufacturing of estrogen patches has doubled over the past year. However, patients still report experiencing stock-outs of the patches. Officials at the FDA's Center for Drug Evaluation and Research highlighted the increased demand for estradiol patches, which "increased significantly" after their label change in February.
The FDA is working to improve access and ramp up production of these products. The agency also aims to revise the labels of the remaining menopause hormone treatments. The decision to remove black-box warnings was made without input from the FDA's advisory committees, sparking criticism from menopause experts who argue that the move sets a concerning precedent.
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