Post-marketing safety study of amyotrophic lateral sclerosis therapeutics based on FAERS
WANG Ling
LIU Lin-hui
PENG Hui
LI Xin-lin
LIU Mao-chang
Abstract：Objective:To conduct signal mining of adverse events caused by amyotrophic lateral sclerosis(ALS)therapeutic drugs,edaravone and riluzole,based on FDA adverse event reporting system(FAERS)to provide reference for clinical drug selection.Methods:All data from the FAERS database from the first quarter of 2004 to the fourth quarter of 2023 were selected for signal monitoring using repotting odds ratio and multi-item gamma Poisson shrinker methods.Results:A total of 2 930 and 1 337 adverse event reports with edaravone and riluzole as the primary suspected drugs were included,respectively,and death had the highest proportion among the serious adverse events.The median occurrence time of adverse events was 25 and 44 days for edaravone and riluzole,respectively,but the adverse events due to both drugs could occur at any time after dosing.Signal monitoring results showed that both drugs were involved in 27 system organ classes and 71 positive signals.The adverse events caused by edaravone were mainly concentrated at general disorders and administration site effects,whereas those caused by riluzole were essentially the same as those in the labelling,and the adverse events to which the clinic need to pay close attention included interstitial lung disease,abnormalities in hepatic function,and pancreatitis.Conclusion:This study provides data on the safety profile of ALS therapeutic drugs,which will help healthcare professionals reduce the risk of adverse events with edaravone and riluzole in clinical practice.
Keywords：edaravoneriluzoleFDA adverse event reporting systemamyotrophic lateral sclerosissafetydata mining
Publication Date：2025-02-14
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 322-329 )