Real-world safety evaluation of brivaracetam: insights from the US FDA Adverse Event Reporting System.

Abstract

Background: Brivaracetam (BRV) is a novel drug for the treatment of epilepsy. This study aimed to detect and characterize adverse events (AEs) associated with BRV from the first quarter of 2016 to the second quarter of 2024 using the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database.

Research design and methods: We utilized disproportionality analysis methods, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS), to assess the associations between reported AEs and BRV usage in the FAERS data.

Results: A total of 1,781 adverse event reports were analyzed, with Brivaracetam as the primary suspected drug. We identified 13 positive system organ classes (SOCs) and 78 positive preferred term signals (PTs), with a particular focus on nervous system disorders, psychiatric disorders, and injury, poisoning, and procedural complications. Exposures related to injury, poisoning, and procedural complications during pregnancy and lactation showed positive signals, including exposure before pregnancy, during breastfeeding, and during pregnancy. These exposures warrant significant attention.

Conclusions: Based on the FAERS database, we conducted a comprehensive analysis of AEs associated with BRV. This study aims to provide guidance for the clinical application of BRV in epilepsy treatment, thereby improving its safety.