pvEBayes: An R Package for Empirical Bayes Methods in Pharmacovigilance

Abstract: Monitoring the safety of medical products is a core concern of contemporary pharmacovigilance. To support drug safety assessment, Spontaneous Reporting Systems (SRS) collect reports of suspected adverse events of approved medical products offering a critical resource for identifying potential safety concerns that may not emerge during clinical trials. Modern nonparametric empirical Bayes methods are flexible statistical approaches that can accurately identify and estimate the strength of the association between an adverse event and a drug from SRS data. However, there is currently no comprehensive and easily accessible implementation of these methods. Here, we introduce the R package pvEBayes, which implements a suite of nonparametric empirical Bayes methods for pharmacovigilance, along with post-processing tools and graphical summaries for streamlining the application of these methods. Detailed examples are provided to demonstrate the application of the package through analyses of two real-world SRS datasets curated from the publicly available FDA FAERS database.