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Monday, November 29, 2021

Fears grow over the safety of Aduhelm after death of patient taking drug

The safety data for these trials was published Monday in the journal JAMA Neurology in a study authored by eight Biogen employees.

The data showed that 425 out of 1,029 patients, or 41 percent, who received the high dose of the drug – the dose that the FDA later approved – experienced either cerebral edema or bleeding. Sixty-four patients were forced to discontinue the study due to tumor or bleeding.

According to the study, the majority of affected patients, 362, experienced edema, and 94 of them reported symptoms. In a statement, Biogen noted that most of the edema occurred early in the treatment period, either when patients received a high dose or shortly after they reached that dose.

A study that reported the same safety data that Biogen submitted to the FDA during the drug review process, states that symptoms such as headaches, confusion, dizziness or nausea were observed in 103 patients who received a dose that was later approved. Less frequent symptoms included fatigue, blurred vision, blurred vision, and gait disturbance.

Biogen said the MRI showed that swelling or bleeding was mild to moderate in most patients with these side effects. However, the study found that the scans showed severe effects in 12 percent of patients with edema, 12 percent of patients with microbleeds, and 22 percent of patients with slow bleeding.

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The study says people with moderate to severe swelling were not taken the drug until the seizure resolved. Patients with mild swelling and no symptoms could continue to take the drug, and the study showed that their swelling did not get worse.

The study says there were no deaths from cerebral edema or bleeding in two trials. In an earlier safety study, one participant died. The 75-year-old woman, who died in September, was involved in extended trials of the drug, Biogen said.

Most patients with cerebral edema or bleeding were carriers of the APOE4 gene mutation, which also increases the risk of developing Alzheimer’s disease. While patients in the studies were more likely to experience a slower decline if they had the APOE4 mutation, the data suggests that they also face higher safety risks from the drug.

World Nation News Deskhttps://www.worldnationnews.com
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