In June, the Food and Drug Administration (FDA) granted accelerated approval for Aduhelm (aducanumab-avwa) as the first and only drug for Alzheimer’s disease. Since then, trials have reported a serious side effect of the drug, according to BioSpace.

There have been cases of amyloid-related imaging abnormalities (ARIA-E), or cerebral edema, in some patients who received the drug.

On November 10, Biogen, the company that develops Aduhelm, said that it was investigating the death of a 75-year-old woman who died of ARIA while receiving the drug. However, it is yet to be determined whether the death was caused by the ARIA.

There were three more cases of ARIA between July and September, requiring hospitalization. Biogen is reviewing the cases.

A study, published Monday in JAMA Neurology, is looking at ARIA in two Phase 3 trials (ENGAGE and EMERGE). Researchers with Biogen, Brown University, University College London, VU University Medical Center, Amsterdam, the Netherlands, California Pacific Medical Center in San Francisco, Bioclinica in Newark, California, and Cytel in Waltham, Massachusetts are conducting the study.

The trials included 3,285 participants with Alzheimer’s who received one or more doses of Aduhelm. Of those, 425 participants (41.3%) who received the drug experienced ARIA and 362 (35.2%) reported ARIA-edema. Of these participants, 94 (26%) had symptoms of headaches, confusion, dizziness, and nausea.

The study authors noted that most of these adverse events were seen early in treatment. They wrote, “These results are consistent with clinical studies of other anti-ABeta antibodies in which ARIA also primarily occurred within the first months of treatment, while the risk of ARIA-E decreased during the subsequent treatment course.”

Now that the drug has been approved by the FDA, monitoring for ARIA outside of clinical trials will occur for the first time, according to BioSpace.

The prescribing information for Aduhelm describes the timing of MRIs for people with asymptomatic ARIA, which is before the seventh and twelfth infusions, or when clinically indicated.

Aduhelm carries a price tag of about $56,000 per patient per year. Many insurance companies and health care systems are refusing to pay for the drug.

Meanwhile, Medicare is still evaluating the Alzheimer’s drug, with an announcement expected shortly, but a final decision is not coming until March or April 2022.