Mining and analysis of adverse drug reactions associated with perampanel based on FAERS database

Abstract

Introduction: Perampanel (PER) is a non-competitive AMPA glutamate receptor antagonist used as an anti-seizure medication. Large post-marketing databases are still lacking for safety analysis of the new generation of anti-seizure medications. Based on the FDA's adverse event reporting system (FAERS) database, this study aimed to investigate, assess, and offer evidence for the safety of PER to support clinical decision-making.

Methods: Perampanel-related adverse reaction signals were mined using the reporting odds ratio (ROR), medicines and healthcare products regulatory agency (MHRA), and Bayesian confidence propagation neural network (BCPNN). The rate and occurrence of reported adverse responses were examined.

Results: With the three methodologies used in combination, 83 signals mostly related to psychosis and different nervous system disorders were detected. Among them, suicide behavior, respiratory depression, hepatotoxicity, cognitive impairment, and other possible novel signals warranted consideration. Further examination of the age and gender differences in the detected signals revealed that elderly patients should be closely monitored for any change in consciousness and the occurrence of movement disorders; male patients should be observed for negative mental reactions like a personal attack and homicidal ideation; and female patients should be watched for the occurrence of negative reactions in memory, weight, vision, liver function, and other specific areas.

Conclusions: This study found that PER had the risk of causing suicide behavior, respiratory depression, hepatotoxicity, and cognitive impairment among other adverse effects. When used clinically, PER should be closely monitored for the occurrence of adverse effects on mental health and behavior. However, these results should be interpreted with caution.

Keywords: Adverse drug reactions; Epilepsy; FAERS database; Perampanel; Safety.