Aduhelm, the Alzheimer’s drug approved this summer in a process that led some FDA advisers to quit, is the subject of new controversy. A 75-year-old woman in Canada participating in a clinical trial died in September after going to the hospital for a seizure, the New York Times reports. The FDA is investigating her case. Biogen, which developed Aduhelm, said in a statement that the cause of that patient’s death is still unknown, and they are investigating, too. The hospital where the woman died diagnosed her with brain swelling, a side effect noted in a new study in JAMA Neurology.
The study showed approximately 40% of patients experienced amyloid-related imaging abnormalities—ARIA—which mean they had some swelling or small hemorrhages, and most of the affected patients experienced symptoms such as headache, confusion, or nausea. The bleeding turned up in 19% of patients, per Bloomberg. A biotech analyst with a medical degree who works for an investment bank sent a report to his clients saying the drug probably caused the woman’s death. Biogen said the report, from Brian Abrahams at RBC Capital Markets, “only provides a partial view of the case."
There’s an FDA warning on the drug’s label regarding these side effects. But what the labeling doesn’t mention is that people with a history of problems with their heart, liver, or kidney, or are taking blood thinners, were excluded from the trial. Dr. Sam Gandy of Mount Sinai Center for Cognitive Health said he’s worried that “things may look worse in the real world than they did under these very controlled conditions.” (Read more Aduhelm stories.)