Detection and analysis of signals of adverse events induced by deferasirox based on FAERS

doi:10.19803/j.1672-8629.20240031

Abstract

Abstract: Objective To provide reference for clinical safe medication by exploring adverse event reports of deferasirox. Methods The adverse event (AE) reports of deferasirox collected between November 2005 and September 2023 were retrieved from FAERS database, and classified according to the system organ class (SOC) and preferred term (PT). Suspicious risk signals were mined and analyzed using the reporting odds ratio (ROR) and information component (IC) method. Results A total of 19 657 AEs related to deferasirox as the primary suspect were reported. The male-to-female ratio was 1.04 : 1 and the age mainly ranged from 18 to 85 years old (7 948 cases, 40.43%). A total of 870 AE signals were detected, involving 20 SOC. Among the top 20 PTs of reports, 4 positive signals were not mentioned in drug instructions, including infections, infestations (2 signals), general disorders and administration site conditions (2 signals). Conclusion In clinical use of deferasirox, clinicians should be alert not only to adverse reactions, but to the risk of infection, cerebrovascular accidents, constipation and hypersensitivity myocarditis so as to ensure the safety of medication for patients.

Key words: deferasirox, FDA adverse event reporting system(FAERS), adverse event, signal detection, ROR, IC, infections, infestations, general disorders, administration site conditions

CLC Number:

R973
R994.11

ZHONG Hong, CHEN Hong, ZHANG Xuanyi, DENG Huiyuan, LUO Xianglin, WAN Jie, KONG Wenqiang. Detection and analysis of signals of adverse events induced by deferasirox based on FAERS[J]. Chinese Journal of Pharmacovigilance, 2024, 21(8): 931-935.

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https://zgywjj.magtechjournal.com/EN/Y2024/V21/I8/931

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