An analysis of suicidal and self-injurious behavior reports with antiseizure medications in the FDA adverse event database. Epilepsy Res 2024 Jul;203:107382
Date
05/19/2024Pubmed ID
38761467DOI
10.1016/j.eplepsyres.2024.107382Scopus ID
2-s2.0-85193210316 (requires institutional sign-in at Scopus site) 1 CitationAbstract
BACKGROUND: Pharmacovigilance systems such as the FDA Adverse Event Reporting System (FAERS), are established models for adverse event surveillance that may have been missed during clinical trials. We aimed to analyze twenty-five anti-seizure medications (ASMs) in FAERS to assess for increased reporting of suicidal and self-injurious behavior.
METHODS: Twenty-five ASMs were analyzed: brivaracetam, cannabidiol, carbamazepine, clobazam, clonazepam, diazepam, eslicarbazepine, felbamate, gabapentin, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, perampanel, phenobarbital, phenytoin, pregabalin, primidone, rufinamide, stiripentol, tiagabine, topiramate, valproate, vigabatrin, zonisamide. Reports of "suicidal and self-injurious behavior" were collected from January 1, 2004, to December 31, 2020, using OpenVigil 2.1 tool with indication as "Epilepsy". Relative reporting ratio, proportional reporting ratio, and reporting odds ratio were calculated utilizing all other drug reports for epilepsy patients as a control.
RESULTS: Significant relative operating ratio, ROR (greater than 1, p<0.05) were observed for diazepam (2.909), pregabalin (2.739), brivaracetam (2.462), gabapentin (2.185), clonazepam (1.649), zonisamide (1.462), lacosamide (1.333), and levetiracetam (1.286).
CONCLUSIONS: Of the 25 ASMs that were analyzed in this study, 4 (16%) were identified to have been linked with a likely true adverse event. These drugs included diazepam, brivaracetam, gabapenetin, and pregabalin. Although several limitations are present with the FAERS database, it is imperative to closely monitor patient comorbidities for increased risk of suicidality with the use of several ASMs.
Author List
Porwal MH, Razzak AN, Kumar V, Obeidat AZ, Sharma UAuthor
Ahmed Zayed Obeidat MD, PhD Associate Professor in the Neurology department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AdolescentAdult
Adverse Drug Reaction Reporting Systems
Aged
Anticonvulsants
Child
Databases, Factual
Female
Humans
Male
Middle Aged
Pharmacovigilance
Self-Injurious Behavior
Suicide
United States
United States Food and Drug Administration
Young Adult
