Hui Jing¹, Jing Tang¹, Yan Zhang², Xiting Tang¹, Chengliang Wang¹* and Li Chen^3-5

¹Department of Pharmacy, People's Hospital of Ganzi Tibetan Autonomous Prefecture, Kangding 626000, China
²People's Hospital of Ganzi Tibetan Autonomous Prefecture, Kangding 626000, China
³Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, Sichuan, China
⁴Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China
⁵Department of Pharmacology, Faculty of Medicine and Nursing, University of the Basque Country, Leioa, Spain

*Corresponding Author: Chengliang Wang, Department of Pharmacy, People's Hospital of Ganzi Tibetan Autonomous Prefecture, Kangding 626000, China.

Received: June 23, 2025; Published: June 30, 2025

Abstract

Objective: This study aimed to systematically evaluate the safety profile of perampanel in pediatric patients by analyzing adverse drug events (ADEs) reported in the FDA Adverse Event Reporting System (FAERS) database, identifying potential safety signals, and characterizing adverse drug reactions (ADRs) not documented previously.

Methods: A retrospective pharmacovigilance analysis was conducted using ADE reports from the FAERS database between 2012 and 2024, covering 52 consecutive quarters. The study population was stratified into four age groups: infants (0-2 years), preschool children (2-6 years), children (6-13 years), and adolescents (13-18 years). The Reporting Odds Ratio (ROR) and MHRA methods were applied to identify significant safety signals.

Results: A total of 394 ADE reports associated with perampanel use in minors were analyzed. The most frequently reported adverse reactions included aggression, somnolence, and seizures, with notable variations observed across different age groups. The most common adverse events were neurological and psychiatric disorders, such as aggression, epilepsy exacerbation, and somnolence. Several previously unrecognized adverse drug reactions (ADRs), including acute kidney injury, respiratory failure, psychotic disorders, and urinary retention, were identified.

Conclusion: The analysis identified significant safety signals for perampanel in pediatric populations, particularly involving neurological and psychiatric systems. Clinicians should implement individualized monitoring strategies tailored to different pediatric age groups to effectively detect and manage potential ADRs. Future prospective and comparative studies are recommended to further verify these signals and explore their underlying mechanisms, ensuring safer and more effective clinical use of perampanel in minors.

Keywords: Perampanel; Pediatric Population; FAERS; Adverse Drug Reactions; Signal Detection; Pharmacovigilance

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Citation

Citation: Chengliang Wang., et al. “Safety Evaluation of Perampanel in the Pediatric Population: FAERS Database Analysis and Signal Mining". Acta Scientific Pharmaceutical Sciences 9.7 (2025): 40-50.

Copyright

Copyright: © 2025 Chengliang Wang., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.