A real-world disproportionality analysis of FDA adverse event reporting system (FAERS) events for ramucirumab.

Abstract

Ramucirumab (IMC-1121B) is a fully humanimmunoglobulin G1 monoclonal antibody, approved by the US Food and DrugAdministration (FDA) for treating various cancers, including gastric,colorectal, liver, and non-small cell lung cancer. This study aimed to investigatethe adverse events (AEs) associated with ramucirumab by utilizing data miningtechniques on the FDA Adverse Event Reporting System (FAERS). We collected ramucirumab-related data fromthe FAERS database, spanning from January 2014 to June 2023. Our analysisincorporated both Frequentist and Bayesian methodologies in disproportionalityanalysis to determine the relationship between the drug and specific AEs. Among the14,605,547 reports in FAERS database 12,692,407 were identified as primarysuspected AEs related to ramucirumab. These AEs involved 26 different organsystems, with 24 significant disproportionality Preferred Terms (PTs)identified across four algorithms. Notably, unexpected significant AEs, such asperipheral neuropathy, hemolytic uremic syndrome, rectal stenosis, anaphylacticshock, bladder tamponade, hydronephrosis, and spontaneous pneumothorax, werealso observed. This study makes a significant contributionto the field by emphasizing the importance of long-term monitoring of approvedagents to further expand on potential adverse events and to distinguish betweenevents that are disease-related versus those more directly related to theparticular treatment.