FDA removes black-box warnings from three menopause estrogen patches without advisory panel
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U.S. FDA officials said Friday that three more menopause estrogen patches will no longer carry black-box warnings on cardiovascular disease, breast cancer and dementia. The agency did not convene an advisory committee and gave little scientific detail at a briefing, after dropping similar warnings on six treatments in February while patients face patch shortages. When asked for evidence, officials said it could come later; Yale’s Reshma Ramachandran cited a lack of transparency, while deputy director Dorothy Fink emphasized work with manufacturers on supply.
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