Updated: FDA adds warning of 'larger areas of bleeding' in brain to Biogen's Aduhelm label
The FDA last week signed off on a safety-related change to the label of Biogen’s controversial Alzheimer’s drug Aduhelm, which has barely mustered any sales since its approval because payers have refused to cover it.
The new label makes clear that physicians should, “Inform patients that events of intracerebral hemorrhage greater than 1 cm in diameter have been reported infrequently in patients taking ADUHELM, and that the use of antithrombotic or thrombolytic medications while taking ADUHELM may increase the risk of bleeding in the brain.”
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