Drug Safety Monitoring in Children: Performance of Signal Detection Algorithms and Impact of Age Stratification.

ABSTRACT:

Introduction

Spontaneous reports of suspected adverse drug reactions (ADRs) can be analyzed to yield additional drug safety evidence for the pediatric population. Signal detection algorithms (SDAs) are required for these analyses; however, the performance of SDAs in the pediatric population specifically is unknown. We tested the performance of two SDAs on pediatric data from the US FDA Adverse Event Reporting System (FAERS) and investigated the impact of age stratification and age adjustment on the performance of SDAs.

Methods

We tested the performance of two established SDAs: the proportional reporting ratio (PRR) and the empirical Bayes geometric mean (EBGM) on a pediatric dataset from FAERS (2004-2012). We compared the performance of the SDAs with a published pediatric-sp

SUBMITTER: Osokogu OU 

PROVIDER: S-EPMC4982893 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature