Seriousness and outcomes of reported adverse drug reactions in old and new antiseizure medications: a pharmacovigilance study using EudraVigilance database.

ABSTRACT: Introduction: Epilepsy is a widespread disease requiring long-term drug treatment. The aim of this study was to collect information on reported suspected adverse drug reactions (sADRs) of antiseizure medications (ASMs) and study their seriousness and outcomes in various system organ classifications (SOCs). We intended to compare old and new ASMs' ADRs. Methods: Using EudraVigilance (EV) database, we extracted line listings of reported sADRs with different ASMs over the period from January 2012 to December 2021. The list of ASMs was compiled according to the Anatomical therapeutic chemical classification system. The Medical Dictionary for Regulatory Activities version 24.0 was used for determining the SOCs of individual reported preferred terms (PTs) sADRs. In addition, we cal

SUBMITTER: Girgis MMF 

PROVIDER: S-EPMC11307265 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature