from Hacker News

Side effects surface in 40% of patients on Biogen's Alzheimer's drug Aduhelm

by tima101 on 12/17/21, 3:23 AM with 3 comments

• by allears on 12/17/21, 3:43 AM

  Is this the drug that was approved over the objections of the FDA's panel of experts, and that has triggered the biggest rise of Medicare premiums in history? Biogen seems to be pulling off one helluva scam.

• by tima101 on 12/17/21, 3:25 AM

  > The safety data break down like this: 425 out of 1029 patients, or 41.3%, on the 10mg/kg Aduhelm dose experienced ARIA. Serious cases cropped up in 14 of those patients, the JAMA analysis shows. ARIA-edema (ARIA-E), or swelling, was the most common side effect seen in the pooled data, affecting 362 patients, or some 35%. ARIA-microhemorrhage, also known as microbleed, and ARIA-superficial siderosis, which is a type of slow brain bleeding, was observed in 19.1% and 14.7% of patients, respectively.

  > Ninety-four (26%) of the 362 patients with ARIA-E experienced symptoms, most commonly headache, confusion, dizziness and nausea, the analysis shows.

  > Swelling or bleeding were mild to moderate in those patients, but scans did show severe side effects in 12.2% of patients with swelling, 11.7% in patients with microbleeds and 21.9% in patients with slow brain bleeding.