Real-world safety of maribavir: a retrospective study based on signal detection in the FDA adverse event reporting system.

Abstract

Background: Maribavir is a novel antiviral agent targeting cytomegalovirus through inhibition of the UL97 protein kinase, exhibiting a distinct mechanism of action. However, limited data are available on its safety profile post-marketing.

Aim: This study aimed to evaluate the adverse events (AEs) associated with maribavir using the Food and Drug Administration's Adverse Event Reporting System (FAERS), providing insights to inform clinical practice.

Method: We conducted a retrospective analysis of maribavir-related adverse event reports from the FAERS database, spanning the fourth quarter of 2021 to the second quarter of 2024. Signal detection was performed using four statistical methods: the proportional reporting ratio, reporting odds ratio, Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker.

Results: A total of 1372 reports associated with maribavir were identified. Seven significant signals emerged at the system organ class level. At the preferred term level, 76 adverse events (AEs) demonstrated positive signals, including novel events such as pleural effusion, hypersomnia, and anosmia, alongside signals related to ear disorders. The majority of AEs were reported within the first month of maribavir use.

Conclusion: This study identified several new adverse event signals for maribavir, offering healthcare professionals a deeper understanding of its safety profile, which may guide safer clinical usage.