Concerns Grow About the Safety of Aduhelm Following the Death of drug patients, Who Received the Drug Safety results from those studies were published in the journal JAMA Neurology on Monday in a report co-authored by eight Biogen personnel.
According to the study, the majority of the afflicted individuals, 362, exhibited edoema, and 94 of those reported symptoms. The majority of cases of brain swelling disappeared after 16 weeks. According to Biogen, the majority of edoema appeared early in the treatment period, either when drug patients were being ramped up to the high dosage or shortly after they reached that dose.
According to the research, which was based on the same safety data that Biogen gave to the FDA during the drug approval process, symptoms such as headaches, disorientation, dizziness, or nausea occurred in 103 individuals who received the dose that was subsequently authorised. Fatigue, visual impairment, blurred vision, and gait disruption were among the less common symptoms.
According to Biogen, M.R.I.s revealed that edoema or bleeding was mild or moderate in the majority of individuals who had such adverse effects. Despite this, the study found that scans revealed significant consequences in 12% of patients with edoema, 12% of patients with microbleeds, and 22% of drug patients with a sort of slow brain haemorrhage.
According to the study, participants who experienced moderate or severe edoema were taken off the medicine until their episode ended. Those with minor edoema and no symptoms may continue to take the medicine, and their swelling did not worsen, according to the research.
According to the report, there were no deaths as a result of brain enlargement or bleeding in the two studies. One participant died in a previous safety trial. According to Biogen, the 75-year-old lady who died in September was taking part in an extension study of the medicine.
More individuals with brain edoema or bleeding carried the APOE4 gene variant, which increases the chance of developing Alzheimer’s disease. While individuals with the APOE4 mutation appeared to be more likely to have a slowing of deterioration in the studies, the evidence shows they also face increased safety concerns from the medicine.