Difference analysis of ADE signal for irinotecan in adults and children
- VernacularTitle:伊立替康在成人和儿童中的ADE信号差异分析
- Author:
Fang LI
1
;
Xiaohuan DU
1
;
Xiang SHANG
2
;
Wenjuan WANG
1
;
Mi ZHOU
1
;
Zengyan ZHU
1
Author Information
1. Dept. of Pharmacy，Children’s Hospital of Soochow University，Jiangsu Suzhou 215002，China
2. Dept. of Pharmacy，Suzhou Guangji Hospital，Jiangsu Suzhou 215003，China
- Publication Type:Journal Article
- Keywords:
irinotecan;
drug adverse events;
FAERS database;
risk signals;
children
- From:
China Pharmacy
2024;35(11):1369-1373
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To mine and analyze the post-marketing adverse drug event （ADE） signals of irinotecan in adults and children populations， and to provide a reference for clinical safe medication. METHODS ADE reports of irinotecan from the first quarter of 2004 to the first quarter of 2023 in the US FDA adverse event reporting system database were extracted and the risk signals of irinotecan were detected through the reporting odds ratio and proportional reporting ratio. Statistical analysis was performed for ADE reports and signals of patients aged＜18 years （children） and ≥18 years （adults）. RESULTS A total of 8 013 ADE reports with irinotecan as the primary suspect drug were identified， including 7 656 and 357 ADE reports in adults and children， respectively. A total of 518 and 75 ADE signals were detected in the adults and children， and the mainly involved systems and organs including gastrointestinal disorders， blood and lymphatic system disorders， systemic disorders and various reactions at the administration site， etc. Most of the top 20 ADE signals in terms of frequency were documented in the drug instructions of irinotecan. New ADE signals in adults included peripheral neuropathy， oral mucosal inflammation， pulmonary embolism， epidermal nevus syndrome and reproductive toxicity， while hypertension， progressive neoplasms， tumor lysis syndromes， and embolism were new ADE signals in children. CONCLUSIONS The above new suspected high-risk signals not mentioned in the instructions should raise a high level of alertness in clinical practice of irinotecan.
