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Labeling Changes for Aduhelm Detail Risks of ARIA Brain Bleeds

Labeling Changes for Aduhelm Detail Risks of ARIA Brain Bleeds

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.

About Aduhelm

Aducanumab, sold under the brand name Aduhelm, is a medication designed to treat Alzheimer's disease (AD). It is a monoclonal antibody that targets aggregated forms (plaque) of amyloid beta (Aβ) found in the brains of people with Alzheimer's disease to reduce its buildup. It was developed by Biogen and Eisai.

Aducanumab was approved for medical use in the United States by the Food and Drug Administration (FDA) in June 2021, in a controversial decision that led to the resignation of three advisers to the FDA in the absence of evidence that the drug is effective. The FDA stated that it represents a first-of-its-kind treatment approved for Alzheimer's disease and that it is the first new treatment approved for Alzheimer's since 2003. Aducanumab's approval is controversial for numerous reasons including ambiguous clinical trial results regarding efficacy, the high cost of the drug and the very high rate of serious adverse events. The FDA considers it to be a first-in-class medication.

February 16, 2023



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