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Psychiatric disorders associated with newer antiseizure medications: A real-world disproportionality analysis of FDA
Jiahao Li1, Rujia Zhong2, Feng Zhang3
1Department of Molecular Neurobiology, Groningen Institute of Evolutionary Life Science (GELIFES), University of Groningen 9747 AG Groningen, the Netherlands.
Background:
Antiseizure medications (ASMs), particularly newer agents such as levetiracetam, topiramate, and perampanel, are fundamental in treating epilepsy and related disorders. Our study aims to analyze the psychiatric safety profiles of newer ASMs.
Research Design And Methods:
The data were extracted from the US FDA Adverse Event Reporting System (FAERS) database from 2004Q1 to 2024Q2. The analysis focused on the clinical characteristics, the ranking of adverse reactions, the time-to-onset, and the severity proportion of newer ASMs-related psychiatric disorders.
Results:
Disproportionality analysis highlighted a significant association between newer ASMs and psychiatric adverse events (AEs), with drugs like perampanel and levetiracetam showing notably high risks for severe psychiatric outcomes such as aggression, suicidal ideation, and psychosis. The median time-to-onset of psychiatric AEs was 33 days, with a substantial proportion (46.4 %) occurring within the first 30 days of treatment. Among all ASMs, perampanel has the highest severe proportion of ASM-associated psychiatric disorders at 51.5 %.
Conclusions:
Our findings underscore a significant link between the use of newer ASMs and the risk of developing psychiatric disorders, suggesting the need for careful psychiatric assessment and monitoring when prescribing these medications.
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