A pharmacovigilance approach for assessing the occurrence of suicide-related events induced by antiepileptic drugs using the Japanese adverse drug event report database

Dados Bibliográficos

ID15516634
AutoresTakenao Koseki (0000-0002-2889-9586, Fujita Health University, autor correspondente), Mikako Horie (Fujita Health University), Satomi Kumazawa (Fujita Health University), Tetsuo Nakabayashi (0000-0003-4491-4851, Pharmaceuticals and Medical Devices Agency), Shigeki Yamada (0000-0002-3891-1323, Fujita Health University)
Ano2023
Volume13
Páginas1091386-1091386
Data de publicação2023-01-09
Peer ReviewedSim
Open AccessSim
TipoARTICLE
PeriódicoFrontiers in Psychiatry (JOURNAL)
Identificadores do periódicoISSN: 1664-0640 • E-ISSN: 1664-0640
EditoraFrontiers Media (PUBLISHER • CH)
DOI10.3389/fpsyt.2022.1091386
PMID36699485
OpenAlexW4313889182
IdiomaEN
Referências citadas42

Increased suicidality after antiepileptic drug (AED) treatment remains controversial. This study aimed to investigate the occurrence of suicide-related events (SREs) in Japan. SREs signals with AEDs used orally were evaluated by calculating reporting odds ratios (RORs) and information components (ICs) using the Japanese Adverse Drug Event Report (JADER) database from April 2004 to December 2021. Additionally, factors affecting the occurrence of SREs and time-to-onset from the initial AED treatment were analyzed. Of 22 AEDs, 12 (perampanel hydrate, nitrazepam, levetiracetam, clonazepam, clobazam, sodium valproate, phenobarbital, lamotrigine, lacosamide, gabapentin, zonisamide, and carbamazepine) showed signals of SREs. Patients in their 20 and 30 s, female sex, and concomitant use of multiple AEDs affected the occurrence of SREs. In six AEDs, the median time-to-onset of SREs in patients taking all AEDs was <100 days. The pharmacovigilance approach revealed that several AEDs displayed suicidality signals. Female patients, those in their 20 and 30 s, undergoing combination therapy with ≥2 AEDs, and patients early (<100 days from the initial treatment) in the course of AED therapy should be cautioned about SREs

Adverse drug event · Adverse effect · Antiepileptic drug · Database · Drug · Epilepsy · Event (particle physics · Medical emergency · Pharmacovigilance · Psychiatry · Computer Science · Epilepsy research and treatment · Medicine · Pharmacological Effects and Toxicity Studies · Pharmacovigilance and Adverse Drug Reactions · Pharmacology