The New York Times (11/22, Belluck) reports, “Concerns about safety risks of the controversial new Alzheimer’s drug [aducanumab] 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 incident “occurred in late September,” and “between July and September, three other cases of [amyloid-related imaging abnormalities] ARIA were reported to the FDA’s adverse event database, all requiring hospitalization.”
Bloomberg (11/22, Langreth) reports Biogen’s drug “produced brain swelling in 35% of patients who took the approved dose, although most didn’t experience symptoms, company researchers said in a study” published in JAMA Neurology. The study “found that 362 of 1,029 patients who received the approved dose of the drug experienced the side effect, which showed up in brain imaging of people in two big clinical trials of the drug.”
Related Links:
— “Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug “Pam Belluck, The New York Times, November 22, 2021