Real-world safety analysis of deutetrabenazine post-marketing: a disproportionality study leveraging the FDA Adverse Event Reporting System (FAERS) database.

ABSTRACT:

Background

Deutetrabenazine, a selective vesicular monoamine transporter type 2 (VMAT2) inhibitor, has been demonstrated efficacy in treating refractory neurologic disorders such as Tardive Dyskinesia (TD) and Huntington's disease but have potential adverse events (AEs) that require detailed pharmacovigilance. This study aimed to comprehensively assess the safety profile of deutetrabenazine in real-world settings by analyzing AEs reported from the FDA Adverse Event Reporting System (FAERS) database.

Methods

We conducted a retrospective pharmacovigilance study using FAERS data from Q3 2017 to Q3 2024, focusing on deutetrabenazine-related AEs. We applied four disproportionality analysis methods-Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence

SUBMITTER: Qing G 

PROVIDER: S-EPMC11846250 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature