Using an Automated Algorithm to Identify Potential Drug-Induced Liver Injury Cases in a Pharmacovigilance Database.

ABSTRACT:

Introduction

Drug-induced liver injury (DILI) is the most frequent cause of acute liver failure in North America and Europe, but it is often missed because of unstandardized diagnostic methods and criteria. This study aimed to develop and validate an automated algorithm to identify potential DILI cases in routine pharmacovigilance (PV) activities.

Methods

Post-marketing hepatic adverse events reported for a potentially hepatotoxic drug in a global PV database from 19 March 2017 to 18 June 2018 were assessed manually and with the automated algorithm. The algorithm provided case assessments by applying pre-specified criteria to all case data and narratives simultaneously.

Results

A total of 1456 cases were included for analysis and assessed manually. Sufficient data for

SUBMITTER: Pineda Salgado L 

PROVIDER: S-EPMC8408072 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature