Reporting of Thromboembolic Events with JAK Inhibitors: Analysis of the FAERS Database 2010-2019.

ABSTRACT:

Introduction

A potentially elevated risk for pulmonary thrombosis with Janus kinase inhibitors (JAKinibs) was identified, as well as an increased risk for portal vein thrombosis, in ruxolitinib patients. Consequently, the objective of this investigation was to repeat a comprehensive analysis of the US FDA's Adverse Event Reporting System (FAERS) database to assess postmarketing reporting rates of thromboembolic events (TEs) in patients treated with JAKinibs.

Methods

FAERS data (1 January 2010 to 30 September 2019) were searched for reports of all FDA-approved JAKinibs across all indications. For each drug-adverse drug reaction (ADR) pair, the reporting odds ratio (ROR) [two-sided 95% confidence interval (CI)] and empirical Bayesian geometric mean (EBGM) [one-sided 95% lower

SUBMITTER: Setyawan J 

PROVIDER: S-EPMC8280037 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature