FAQ
Kisunla Brain Injury Lawsuit
Eli Lilly’s Alzheimer’s drug Kisunla (donanemab) has been linked to dangerous brain bleeding, swelling, and other serious complications in patients. On March 27, 2025, the European Medicines Agency (EMA) refused marketing authorization for Kisunla, concluding that the drug’s modest benefits do not outweigh the significant risks of potentially fatal brain injuries.
Recent investigations have revealed concerning safety issues with Kisunla, particularly related to a side effect known as amyloid-related imaging abnormalities (ARIA), which involves swelling and potential bleeding in the brain. The evidence suggests that patients were not adequately warned about these serious risks before taking the medication.
If you or a loved one took Kisunla for Alzheimer’s disease and experienced brain bleeding, swelling, or other serious complications, you may be eligible for compensation.
Serious Brain Complications from Kisunla
Kisunla (donanemab) is a monoclonal antibody designed to attach to and reduce amyloid beta plaques in the brain of Alzheimer’s patients. While approved in the US, Japan, China and UK, the medication has been rejected by European regulators specifically due to safety concerns.
Patients taking Kisunla have reported experiencing:
- Brain bleeding (cerebral hemorrhage)
- Brain swelling (cerebral edema)
- Amyloid-related imaging abnormalities (ARIA)
- Severe headaches
- Confusion and disorientation
- Seizures
- Hospitalization
- Permanent neurological damage
- Death
According to data reviewed by European regulators, ARIA occurred in 36.8% of people who received Kisunla compared to 14.9% receiving placebo. Serious ARIA events occurred in 1.6% of Kisunla patients, resulting in multiple deaths during clinical studies.
High-Risk Groups Not Properly Warned
Research has shown that certain patients are at significantly higher risk for brain bleeding when taking Kisunla. People with the ApoE4 gene variant face substantially higher risks of developing serious complications, yet many were not adequately informed of this risk.
A major investigation by The New York Times revealed that during clinical trials:
- Patients with genetic profiles that made them vulnerable to brain injuries were not informed of their personal risk
- Many experienced what researchers classified as “severe” brain bleeding
- Information about individual risk factors was systematically withheld
- Patients were unable to make informed decisions about their treatment
Even after Kisunla’s approval, concerns remain about whether patients and healthcare providers are being fully informed about these risks.
Regulatory Action and Safety Concerns
The European Medicines Agency formally recommended against approving Kisunla in March 2025, stating that the benefits of the medication “were not large enough to outweigh the risks of potentially fatal events due to ARIA.”
The EMA noted:
- Three deaths occurred in Kisunla clinical trials due to ARIA complications
- Even in restricted populations with lower genetic risk, serious ARIA events still occurred
- The drug’s cognitive benefits were modest (slowing decline by only a few months)
- The risk-benefit profile was unacceptable even with enhanced monitoring
If you or a loved one took Kisunla for Alzheimer’s disease and experienced brain bleeding, brain swelling, or other serious complications, you may be eligible for compensation. Contact us today for a free consultation regarding your legal rights.