A real-world disproportionality analysis of FDA Adverse Event Reporting System (FAERS) events for ramucirumab

Ramucirumab (IMC-1121B) is a fully human immunoglobulin G1 monoclonal antibody, approved by the US Food and Drug Administration (FDA) for treating various cancers, including gastric, colorectal, liver, and non-small cell lung cancer. This study aimed to investigate the adverse events (AEs) associated with ramucirumab by utilizing data mining techniques on the FDA Adverse Event Reporting System (FAERS).

We collected ramucirumab-related data from the FAERS database, spanning from January 2014 to June 2023. Our analysis incorporated both Frequentist and Bayesian methodologies in disproportionality analysis to determine the relationship between the drug and specific AEs.

Among the 14,605,547 reports in FAERS database, 12,692,407 were identified as primary suspected AEs related to ramucirumab. These AEs involved 26 different organ systems, with 24 significant disproportionality Preferred Terms (PTs) identified across four algorithms. Notably, unexpected significant AEs, such as peripheral neuropathy, hemolytic uremic syndrome, rectal stenosis, anaphylactic shock, bladder tamponade, hydronephrosis, and spontaneous pneumothorax, were also observed.

This study makes a significant contribution to the field by emphasizing the importance of long-term monitoring of approved agents to further expand on potential adverse events and to distinguish between events that are disease-related versus those more directly related to the particular treatment.