Characterizing the FDA Adverse Event Reporting System (FAERS) as a Network to Improve Pattern Discovery.

Abstract

Introduction: In drug-safety monitoring systems, adverse events (AEs) associated with the use of medical products often consist of complex patterns of clinical events. Network analysis (NA) was used for pattern recognition and characterizing the Vaccine Adverse Event Reporting System (VAERS), but limited applications of NA to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) left its network description incomplete.

Methods: In this analysis, the network properties of FAERS were characterized and leveraged to facilitate pattern discovery. Reported AE information in FAERS is represented using preferred terms (PTs) in Medical Dictionary for Regulatory Activities terminology. The FAERS subsets were analyzed with drugs and PTs as nodes and interconnections as edges. Global characteristics, like the scale-free nature of the distribution, were examined to explore theoretical and structural considerations. Metrics that assess connectivity and edge weighting algorithms based on report co-occurrence or clustering were applied.

Results: Serious AE reports from 2016 to 2023 (2,062,099) were represented as a network of 20,965 nodes (16,847 PTs and 4116 drugs) with more than four million interconnections. Characteristics of FAERS subnetworks were determined with heavy-tailed degree distributions, high local clustering, and low diameters. Complexities related to structural and evolutionary characteristics were revealed as the log-normal model fits the degree distribution better than the power law.

Conclusions: Network-based techniques identified clinically relevant patterns and clustering patterns representative of known adverse drug reactions. Comparisons to VAERS reveal similarities in networks of AE reporting systems. This initial systematic application of NA to FAERS describes the overall network characteristics of the FAERS database and provides insight into the use of network applications in drug safety research.