Mining of Neurological Adverse Events Associated with Valbenazine: A Post-Marketing Analysis Based on FDA Adverse Event Reporting System

Abstract

Background: Valbenazine is commonly used to treat tardive dyskinesia, and we conducted a pharmacovigilance analysis using the Food and Drug Administration Adverse Event Reporting System (FAERS) to evaluate neurological safety signals associated with valbenazine. Methods: Data were collected in FAERS from the second quarter of 2017 to the fourth quarter of 2022 for data cleaning. Neurological adverse event (AE) signals of valbenazine were mined by calculating reporting odds ratios (ROR), information component (IC) and empirical Bayesian geometric mean (EBGM). The serious and non-serious cases and signals were prioritized using a rating scale. Results: The number of neurological AE reports where the primary suspect (PS) drug was 6,116 for valbenazine. Significant AE signals were identified by the prefer term (PT) analysis for valbenazine, including somnolence (ROR 19.56), tremor (ROR 14.87), and tardive dyskinesia (ROR 229.41), among which 18 AEs were identified as new signals. Patient age (p < 0.001) and sex (p = 0.027) might be associated with an increased risk of neurological AE severity. Notably, the association between valbenazine and neurological disorders remained when stratified by sex, age, and reporter type. AE timing analysis was performed for the drug and four moderate clinical priority signals [i.e., somnolence, balance disorder, parkinsonism, and akathisia (priorities 7)], showing the same early failure type profiles. Conclusions: The increase in neurological safety signals is identified in the post-marketing research of valbenazine. Clinicians need to pay attention to not only common AEs but also be alert to new neurological AE signals when using valbenazine.

Note:
Funding Declaration: This study was supported by the Zhengzhou University Young Talents Enterprise Cooperation and Innovation Team Support Program (32310410) and Zhengzhou University Hundred Professors' Teams Assisting Enterprises in High-Quality Innovation and Development Driving Special Project (JSZLQY2021077).

Conflicts of Interest: None

Keywords: Valbenazine, Pharmacovigilance, Neurological adverse events, Post-marketing surveillance, Disproportionality analysis