Bevacizumab-Associated Pancreatitis: Cases Reported to the Adverse Event Reporting System of the Food and Drug Administration

Introduction: Bevacizumab binds to and inhibits vascular endothelial growth factor (VEG-F). In theory, blocking of VEG-F could enhance the severity of acute pancreatitis. We searched the FDA Adverse Event Reporting System (FAERS) database for cases of pancreatitis potentially related to bevacizumab use. Methods: Using the FAERS database, 3,171,655 individual adverse event reports between January 2003 and June 2012 were downloaded and analyzed using SPSS 20 (IBM Co, Armonk, NY, USA). A search was undertaken for reactions of “pancreatitis” with bevacizumab, regardless of indication. All reports were then limited to “primary suspect” cases for bevacizumab, meaning the reporter believed that bevacizumab was the main cause of drug-induced pancreatitis. The identified cases were organized with respect to indication for bevacizumab use, age, gender, and type of pancreatitis. In addition, a PubMed search was conducted using the MESH terms “pancreatitis” and “bevacizumab”, separated by the Boolean operator “AND”. Results: Total of 116 cases of pancreatitis were identified in FAERS, including 22 cases of acute pancreatitis, 1 case of hemorrhagic pancreatitis, and 2 cases of necrotizing pancreatitis. The average age of patients reported was 54.6 years, with females accounting for 55%. The most common indication for bevacizumab use in this patient group was colorectal cancer (44 cases). Deaths were reported in 11 cases (9.5%). No previously described cases of bevacizumab-associated pancreatitis were found in the medical literature. Conclusion: A small number of cases describing the association of bevacizumab with pancreatitis have been reported to FAERS. Despite the use of bevacizumab in patients with underlying cancer, mortality from pancreatitis in this setting appears to be uncommon.Table 1