基于OpenFDA数据库的伏硫西汀不良事件报告信号挖掘与分析

doi:10.3969/j.issn.1006-5253.2023.02.002

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Abstract Objective To evaluate the reports of adverse events of vortioxetine and data analysis to provide reference for drug safety in clinical practice.Methods The data of vortioxetine adverse events from September 2013 to August 2022 were retrieved from OpenFDA database, and risk signals were mined using the Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) methods of the Ratio Imbalance Method. Statistical classification and analysis of the mined signals were performed using the preferred system organ class (SOC) of the Medical Dictionary for Regulatory Activities (MedDRA).Results Totally 16 569 reports of vortioxetine related adverse events were retrieved, with a predominantly adult population and a higher proportion of female patients (62.2%). The top 3 reporting countries were USA, France and Canada. The reporting population was mainly consumers or nonhealth professionals, accounting for 47.8%. The main indication was depression. The proportion of serious adverse events was 45.1%. Fifty suspicious signals were screened according to the positive criteria, involving a total of 10 SOC classifications, with psychiatric disorders having the highest number of signals (20), followed by systemic disorders and various reactions at the site of administration (9). Twenty-five of the 50 suspicious signals were consistent with the instructions. Among the 50 suspicious signals, the top 3 signals in terms of intensity were feeling guilty (ROR=171.616, PRR=169.288), decreased appetite (ROR=92.452, PRR=91.141) and apathy (ROR=38.309, PRR=37.404).Conclusion Based on the OpenFDA database, the adverse event data of vortioxetine can help to identify the potential risk signals of vortioxetine in the real world, suggesting that clinics should pay attention to these potential risk signals not mentioned in the instructions, in addition to those included in the instructions, and take timely interventions to ensure the drug safety of patients.

Key words： vortioxetine OpenFDA adverse drug event

Received: 06 December 2022

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Wu Xuqi,Ge Chenjie. Signal mining and analysis of vortioxetine adverse event reports based on OpenFDA database[J]. journal1, 2023, 30(2): 87-92.

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http://manu58.magtech.com.cn/Jwk_zgyytj/EN/10.3969/j.issn.1006-5253.2023.02.002 OR http://manu58.magtech.com.cn/Jwk_zgyytj/EN/Y2023/V30/I2/87

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