Risk signal mining of adverse events related to baloxavir marboxil based on the US FDA Adverse Event Reporting System
10.3760/cma.j.cn114015-20230403-00249
- VernacularTitle:基于美国FDA不良事件报告系统数据库的玛巴洛沙韦不良事件风险信号挖掘
- Author:
Xiangrong BAI
1
;
Yangai WANG
1
;
Bing CHEN
1
Author Information
1. 首都医科大学宣武医院药学部，北京 100053
- Publication Type:Journal Article
- Keywords:
Influenza, human;
Adverse drug reaction reporting systems;
United States Food and Drug Administration;
Signal mine;
Baloxavir marboxil
- From:
Adverse Drug Reactions Journal
2023;25(12):712-716
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To mine the risk signals of baloxavir marboxil-related adverse events (AEs) and provide reference for rational use in clinical practice.Methods:The report odds ratio (ROR) and proportional reporting ratio (PRR) methods were used to mine the risk signals of baloxavir marboxil-related AEs in the US Food and Drug Administration Adverse Event Reporting System (FAERS) from the 1st quarter of 2018 to the 4th quarter of 2022. The AE with reports ≥3 and 95% confidence interval ( CI) lower limit of ROR or PRR>1 was defined as a risk signal. AEs were classified according to the system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities (MedDRA) 25.1 for statistical analysis. Results:A total of 1 102 AE reports were retrieved, involving 1 102 patients, and 498 were serious AE. A total of 45 AE risk signals were obtained by ROR and PRR methods. The top 10 PTs in signal intensity were febrile seizures, ischemic colitis, bacterial pneumonitis, anaphylaxis, hemorrhagic cystitis, erythema multiforme, melena, anaphylactic shock, disseminated intravascular coagulation, and anaphylactic reaction. Of them, 26 PTs were not recorded in the labels, in which the top 10 PTs were febrile seizures, ischemic colitis, bacterial pneumonia, hemorrhagic cystitis, disseminated intravascular coagulation, altered mental status, fever, rhabdomyolysis, cyanosis, and facial paralysis. The top 5 SOCs that involved more PTs were nervous system disorders, gastrointestinal disorders, respiratory system diseases, psychiatric disorders, and blood and lymphatic system disorders. Among the 498 serious AEs, a total of 5 risk signals were mined, including infectious pneumonia, diarrhea, rhabdomyolysis, allergic reactions, and abnormal behavior.Conclusion:The attention should be paid to AEs not mentioned in the drug label in clinical application of baloxavir marboxil, such as febrile seizures, bacterial pneumonia, ischemic colitis, and hemorrhagic cystitis.
