Study on the risk signal mining related to montelukast in pediatric patients based on the US FDA Adverse Event Reporting System Database
10.3760/cma.j.cn114015-20230227-00121
- VernacularTitle:基于美国FDA不良事件报告系统数据库的儿童患者应用孟鲁司特风险信号挖掘
- Author:
Yanhui LIU
1
;
Wenyi RUAN
1
;
Huiying CHEN
1
;
Kangkang MEI
1
;
Heping CAI
1
Author Information
1. 安徽省儿童医院临床药学部，合肥 230000
- Publication Type:Journal Article
- Keywords:
Anti-asthmatic agents;
Leukotriene antagonists;
Child;
Data mining;
Adverse event reporting system database;
Montelukast
- From:
Adverse Drug Reactions Journal
2023;25(8):469-474
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the risk signals of montelukast-related adverse events (AEs) in pediatric patients and provide reference for the safe use.Methods:AE reports of children with montelukast as the primary suspect drug from the first quarter of 2004 to the third quarter of 2022 were collected by searching the US FDA Adverse Event Reporting System database (FAERS). AEs were standardized and classified according to the preferred terms (PT) and system organ class (SOC) of Medical Dictionary for Regulatory Activities 23.0. Proportional reporting odds ratio (PRR) method was used to mine the AE risk signals of montelukast. An AE with reports ≥3, PRR≥2, and χ2>4 was defined as a positive signal, which were analyzed using descriptive method. Results:A total of 5 179 AE reports were included in the analysis, involving 1 295 PTs, and 233 positive PTs were obtained by PRR method. The top 10 PTs in AE reports were aggressive behavior, anxiety, suicidal ideation, abnormal behavior, depression, anger, nightmares, insomnia, crying loudly and night terrors. Except crying loudly, all of them were adverse reactions recorded in the label. The top 10 PTs in signal intensity were sensory overload, arrhythmia, separation anxiety disorder, loneliness phobia, dust allergy, Mille-Fisher syndrome, eosinophilic granuloma complicated with polyangitis, personality disorder in children, night terrors and decreased platelet adhesion. Among them, abnormal heart rate, Mille-Fisher syndrome and decreased platelet adhesion were not recorded in the label. A total of 59 of the 233 positive PTs were not recorded in the label, involving 10 SOCs. The top 5 SOCs were social environment, mental illness, injury, poisoning and surgical complications, general conditions and administration site, and respiratory, thoracic and mediastinal diseases.Conclusion:The main AEs of pediatric patients receiving montelukast treatment in the US FAERS are aggressive behavior, anxiety, depression, insomnia, night terrors, etc., all of which are adverse reactions recorded in the label; adverse reactions not recorded in the drug label include abnormal heart rate, Miller-Fisher syndrome, and decreased platelet adhesion.
