Adverse Signals of Celecoxib Associated with Central Nervous System and Cancer: A Retrospective Analysis of the FDA Adverse Event Reporting System

Abstract

Abstract Purpose Some of the COX-2 inhibitors are now clinically recognized as candidates for the treatment of various neurological disorders and cancers, especially celecoxib. We performed this pharmacovigilance analysis using the Food and Drug Administration Adverse Event Reporting System (FAERS) database to explore the mechanisms associated with Celecoxib in adverse events (AEs). Methods Mining data from the FAERS database of AEs in which the primary suspect drug was celecoxib. In this study, disproportionality analysis was used to detect potential positive signals between celecoxib and related adverse events. It includes proportional reporting ratio (PRR), reporting odds ratio (ROR), Bayesian confidence propagation neural network (BCPNN) and empirical Bayesian geometric mean (EBGM). Use software such as Microsoft Office Excel (EXCEL) and R Studio for processing and statistical analysis. Results A total of 111,59092 AE reports were extracted from FAERS and 32841 AE reports with celecoxib as the primary suspected drug were obtained. Celecoxib adverse reactions were mainly reported in cardiac disorders (n = 9602) and nervous system disorders (n = 4045). The number of reports of cerebrovascular accident (n = 3109, IC025 = 3.24) and cerebrovascular disorder (n = 265, IC025 = 5.06) and the signal strength of the two nervous system-related adverse reactions were inconsistent with the description in the labels. Discovery of 9 unexpected and serious AEs, such as Stevens-Johnson syndrome, male breast disease, and squamous cell carcinoma of the head and neck. Conclusions This study is consistent with clinical reports. In addition, unexpected AEs of celecoxib in neurological diseases and cancer were found, providing monitoring and risk identification for future clinical applications of celecoxib.