Signal mining and analysis of adverse drug events for gilteritinib
- VernacularTitle:吉瑞替尼的不良事件信号挖掘与分析
- Author:
Yang LIU
1
;
Minzhen HAN
1
;
Jie XIA
1
;
Hanshuai HU
1
;
Lei YAO
1
;
Xue LAN
1
;
Qian LIU
1
;
Jinxingyi WANG
1
Author Information
1. Dept. of Pharmacy，the Second Affiliated Hospital of Guizhou Medical University，Guizhou Kaili 556000，China
- Publication Type:Journal Article
- Keywords:
gilteritinib;
adverse drug events;
pharmacovigilance;
data mining
- From:
China Pharmacy
2024;35(15):1888-1892
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To mine the adverse drug events （ADE） signals for gilteritinib， and provide a reference for safe drug use in clinic. METHODS ADE reports with gilteritinib as the primary suspected drug were extracted from the FDA Adverse Event Reporting System （FAERS） database from February 1st， 2018 to December 31st， 2023. Reporting odds ratio （ROR） and proportional reporting ratio （PRR） were applied to detect the risk signals from the data in the FAERS database. The classification and statistics of collected signal data were conducted by using the preferred term （PT） and systemic organ class （SOC） in ADE terminology set of the Medical Dictionary for Regulatory Activities （24.1 edition）. RESULTS Totally， 2 755 gilteritinib-related ADE reports were collected from the database， involving 676 ADE signals （95 positive signals）， 313 PTs and 25 SOCs. Among them， nine signals were not recorded in the package insert. The top 5 PTs consisted of abnormal liver function， decreased platelet count， febrile neutropenia， pneumonia and myelosuppression. The top 6 SOCs for positive signal counts were examinations， general disorders and administration site conditions， respiratory， thoracic and mediastinal disorders， infections and infestations， heart organ disorders， and nervous system disorders. ADEs not recorded in the drug package insert included pneumonia， myelosuppression， decreased blood cell count， sepsis， hemorrhage， infection （not specifically referred to）， septic shock， respiratory failure， and aspergillosis. CONCLUSIONS In addition to paying attention to common ADEs such as liver dysfunction and thrombocytopenia， it is necessary to monitor ADEs with strong signals that are not mentioned in the drug instructions when using gefitinib， such as pneumonia， bone marrow suppression， cytopenia， sepsis， bleeding， infection （not specifically referred to）， septic shock， respiratory failure， Aspergillus infection， elevated serum creatinine and interstitial lung disease.
