Safety concerns for Alzheimer’s drug after woman dies –
Aduhelm causes brain swelling and bleeding. Yet patients use it.
There have been a ton of concerns about the new Alzheimer’s treatment drug, Aduhelm, especially after a 75-year-old Canadian woman suffered brain swelling and died. She had received infusions as a participant in a clinical trial. The woman’s death occurred in September and was reported to the Food and Drug Administration (FDA) adverse event reporting system. Now the agency and drug maker Biogen are investigating the circumstances of his death.
In a statement, Biogen said, âThe cause of death is unknown at this time. We know that the 75-year-old patient in the clinical trial was admitted to the hospital with a seizure and was diagnosed with swelling of the brain. Following an extended hospital stay, the patient was being prepared for discharge when she deteriorated and was transferred to another facility. We requested missing information, including brain imaging, from the last nine critical days of hospitalization. “
Dr Brian Abrahams, biotechnology analyst at RBC Capital Markets, obtained the medical report which indicated that the swelling in the brain was probably “caused by aducanumab”. He also said the patient “did not appear to have any other contributing conditions listed.”
Biogen said that “the RBC report provides only a partial view of the matter.” He was quick to add, “We take this event very seriously and continue to work with the reporting investigator.”
Swelling of the brain and bleeding from the brain are known to be possible side effects of Aduhelm. However, the FDA approved the drug even though a board of senior officials, an external expert advisory committee, and many Alzheimer’s disease experts said it was “not clear whether Aduhelm could be of benefit to patients. patients and that the drug carried serious risks of harm “.
The FDA has added a warning to the drug’s label stating that Aduhelm can cause “amyloid-related imaging abnormalities (ARIA)” and advises doctors to “monitor patients and get two brain MRIs at during the first year of treatment â. The American Academy of Neurology explained that “the FDA label calls for less frequent monitoring than that performed in clinical trials” and said that “additional MRIs will often be required in response to changes in clinical condition. patients”.
Dr Sam Gandy, an Alzheimer’s physician and director of the Mount Sinai Center for Cognitive Health, said one of the biggest concerns was: âPatients in Aduhelm’s clinical trials were healthier than they were. many people with Alzheimer’s disease who could use the drug now that it is available. People were excluded from participating in the trials if they had medical conditions that many older people have, including previous heart problems, any signs of liver or kidney failure, or if they were taking blood thinners. Now if these common comorbidities are not ruled out and its kind all comers. I’m concerned that things may look worse in the real world than they were under these very controlled conditions. “
Gandy also said that one of his own patients took part in an Aduhelm clinical trial and suffered ten brain micro-hemorrhages in about a year, which had dismissed him from the trial. Two previous Phase 3 clinical trials of Biogen also took place before the company sought FDA approval and these were halted in 2019 after an oversight committee concluded it did not appear to be helping. the patients.
Safety data from these trials were recently published in JAMA Neurology, showing that â425 of 1,029 patients,â nearly half, who received the âhigh dose of the drug, which the FDA subsequently approved, experienced brain swelling or bleeding. Sixty-four patients had to stop participating in the trials due to swelling or bleeding. “Of the affected patients,” 362 presented with swelling and 94 of them reported symptoms. “
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