The real-world safety of lacosamide and perampanel in children: a disproportionality analysis of the FDA Adverse Event Reporting System.

Background: Lacosamide and perampanel are two novel antiepileptic drugs with distinct mechanisms of action. However, the real-world evidence of adverse events (AEs) related to these drugs in children is limited. Objectives: This study aims to explore the AE profiles of lacosamide and perampanel in children by mining the FDA Adverse Event Reporting System (FAERS). Design: A retrospective disproportionality analysis of the FAERS database was conducted. Methods: Reports were collected and analyzed from the first quarter of 2009 to the third quarter of 2024. Four disproportionality analysis were employed in data-mining process to detect signals in children, including the reporting odds ratio, the proportional reporting ratio, the Bayesian confidence propagation neural network, and the multiitem gamma Poisson shrinker algorithms. Results: A total of 1017 AE reports of lacosamide and 349 AE reports of perampanel deemed as the "primary suspect" were retrieved in children. After being categorized and summarized by the number of reports in system organ class, the top 3 for lacosamide were nervous system disorders, general disorders and administration site conditions, injury, poisoning and procedural complications, the top 3 for perampanel were psychiatric disorders, nervous system disorders, infections, and infestations. Both lacosamide and perampanel had significant effects on the nervous system. Lacosamide was more prone to multidrug resistance and cardiac disorders, while perampanel was more likely to affect psychiatric system. Conclusion: Our study identified potential new AE signals for lacosamide and perampanel. The findings warned the need for cautious therapeutic decisions during pregnancy and emphasized the importance of rational use of drugs and correct medication education. This postmarketing study provided reference data for the clinical monitoring and treatment of lacosamide and perampanel in children. Our study merely proved the statistical correlations; further research is needed to clarify the causal relationship between the drug and the AEs.