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Labeling Changes for Aduhelm Detail Risks of ARIA Brain Bleeds

February 16, 2023

The FDA has updated the labeling for Biogen’s Alzheimer’s drug Aduhelm (aducanumab-avwa) to include a warning of potential amyloid-related imaging abnormalities (ARIA), which can lead to brain bleeding and swelling, and in some cases, intracerebral hemorrhage greater than one centimeter.

ARIA most often are “temporary swelling in areas of the brain that usually resolves over time” the update says, adding that while this swelling does not always cause symptoms, some patients have experienced headache, confusion, dizziness, vision changes, nausea, aphasia, weakness, or seizure.

The updated labeling says healthcare providers should tell patients that taking antithrombotic or thrombolytic medications with Aduhelm may increase the risk of bleeding in the brain.

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