Risk signal mining of adverse events of drug-related capillary leak syndrome: a study based on the US Food and Drug Administration Adverse Event Reporting System database
10.3760/cma.j.cn114015-20240831-00028
- VernacularTitle:药物相关性毛细血管渗漏综合征风险信号挖掘：基于美国FDA不良事件报告系统数据库的研究
- Author:
Ye KANG
1
;
Yingrui LI
;
Xiao ZHANG
Author Information
1. 北部战区总医院药剂科，沈阳 110016
- Publication Type:Journal Article
- Keywords:
Capillary leak syndrome;
Drug monitoring;
Data mining;
Adverse drug event reporting system
- From:
Adverse Drug Reactions Journal
2025;27(7):409-414
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To mine the drugs that may cause capillary leak syndrome (CLS), and evaluate the risk of CLS, and provide reference for safe and rational use of drugs in clinic.Methods:Adverse event (AE) reports with the preferred term "capillary leak syndrome" from the 1st quarter of 2004 to the 4th quarter of 2023 were collected by searching US Food and Drug Administration Adverse Event Reporting System (FEARS) database. Reporting odds radio (ROR) method and proportional reporting ratio (PRR) method were used to mine the AE risk signals. Drugs with report number ≥3, lower limit of the 95% confidence interval ( CI) of ROR value >1, PRR ≥2, χ2 ≥4 were grouped and classified according to the Anatomical Therapeutic Chemical Classification (ATC) system. The top 20 drugs in ROR values were selected, and a risk assessment for drugs potentially causing CLS was performed by reviewing drug labels, adverse reaction datasets, and relevant literature. Results:A total of 1 033 AE reports related to CLS were collected, involving 558 primary suspected drugs associated with CLS. The top 5 types of drugs that the most commonly causing CLS were antineoplastic and immunomodulating agents, systemic hormonal preparations, anti-infectives for systemic uses, cardiovascular system, and alimentary tract and metabolism. The risk assessment results showed that 13 drugs of the top 20 drugs in signal intensity (clofarabine, gemcitabine, interleukin-3, denileukin diftitox, dinutuximab, filgrastim, trabectedin, cytarabine, busulfan, docetaxel, trastuzumab, vildagliptin and melphalan) were high-risk drugs causing CLS, among which cytarabine, docetaxel, busulfan, trastuzumab, vildagliptin, and melphalan were not recorded to cause CLS in the labels. The other 7 drugs (asparaginase, fludarabine, amphotericin B, bosutinib, daunorubicin, ponatinib, and bleomycin) were low-risk drugs causing CLS.Conclusions:Thirteen drugs are high-risk drugs that may cause CLS, among which cytarabine, docetaxel, busulfan, trastuzumab, vildagliptin and melphalan are not recorded causing CLS in the labels. It is suggested that clinicians and pharmacists should be vigilant against high-risk drugs, especially those not recorded causing CLS in the labels.
