Analysis of postmarketing neuropsychiatric adverse events of avapritinib based on the FDA adverse event reporting system.

ABSTRACT: Neuropsychiatric adverse events (AEs) significantly impact the quality of life of patients using avapritinib. However, the majority of current data comes from pre-marketing, with limited real-world studies. Our research aimed to explore post-marketing data of avapritinib. We evaluated the signals of avapritinib-related neuropsychiatric AEs by data mining using the FDA Adverse Event Reporting System (FAERS). Reporting odds ratio (ROR) and information component (IC) were employed to quantify the signals from the first quarter of 2020 through the fourth quarter of 2023. Subsequently, stratified analyses were conducted to further explore the effect of different stratification schemes on the association between avapritinib and neuropsychiatric AEs. Finally, a combination medication analysis was

SUBMITTER: Mao W 

PROVIDER: S-EPMC11760955 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature