Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug
The New York Times
Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many cases were asymptomatic.
Concerns about safety risks of the controversial new Alzheimer’s drug Aduhelm have intensified in the wake of the death of a 75-year-old woman who experienced brain swelling after receiving infusions of the drug as a participant in a clinical trial.
The death of the woman, who lived in Canada, occurred in late September and was reported by a doctor to the Food and Drug Administration’s adverse event reporting system this summer. It is being investigated by both the F.D.A. and Biogen, which makes the drug, also known by its scientific name, aducanumab.
In a statement Biogen said: “The cause of death is unknown at this time. We know the 75-year-old clinical trial patient was admitted to the hospital with a seizure” and diagnosed with brain swelling.
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