Study on the risk signal mining related to brigatinib based on the US FDA Adverse Event Reporting System
10.3760/cma.j.cn114015-20220822-00771
- VernacularTitle:基于美国FDA不良事件报告系统数据库的布格替尼风险信号挖掘
- Author:
Zhonghua FU
1
;
Zihan GUO
;
Mengmeng WANG
;
Qiong DU
;
Qing ZHAI
Author Information
1. 河南省人民医院药学部，郑州 450003
- Publication Type:Journal Article
- Keywords:
Protein-tyrosine kinases;
Enzyme inhibitors;
Data mining;
Brigatinib;
Adverse events
- From:
Adverse Drug Reactions Journal
2023;25(1):34-39
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the risk signals of brigatinib-related adverse events (AEs) and provide reference for the safe use in clinical practice.Methods:The US FDA Adverse Event Reporting System database was searched and AE reports on brigatinib as the primary suspect drug from April 1, 2017 to March 31, 2022 were collected. AEs were standardized and classified according to the preferred terms (PT) and system organ class (SOC) of Medical Dictionary for Regulatory Activities 24.0. Reported odds ratio ( ROR) and proportional reporting odds ratio ( PRR) methods were used to mine the AE risk signals of brigatinib. An AE with reports ≥3, ROR≥2, 95% confidence interval ( CI) lower limit of ROR>1, or reports ≥3, PRR≥2, and χ2>4 was defined as a positive signal. Positive PT signals were analyzed using descriptive method. Results:A total of 1 564 AE reports were included in the analysis, involving 672 PTs. After analysis using ROR and PRR methods, 52 PTs with positive risk signals were obtained, involving 16 SOCs. The top 10 PTs in report amount were fatigue, diarrhea, nausea, cough, abnormal serum creatine phosphokinase, dyspnea, headache, rash, vomiting, and hypertension, all of which were common AEs in the instructions. The top 10 PTs in signal intensity were pituitary infarction, radiation necrosis, elevated amylase, esophageal varices, early saturation, elevated lipase, abnormal serum creatine phosphokinase, pulmonary toxicity, prolonged activated partial thromboplastin time, and photosensitivity. Among them, the PTs ranked 1st, 2nd, 4th, 5th, 8th, and 10th were not recorded in the label. Pneumonia and interstitial lung disease (ILD) were serious AEs, with 31 and 8 reports, respectively. In the 52 PTs, 28 were not included in the drug label, involving 12 SOCs. Conclusions:The main adverse reactions of brigatinib were diarrhea, nausea, cough, and abnormal serum creatine phosphokinase and serious adverse reactions such as pneumonia and ILD were both reported, which were consistent with the common AE recorded in the drug label. In addition, brigatinib might cause pituitary infarction, radiation necrosis, pulmonary toxicity, photosensitivity, etc., which should be vigilant in clinical practice.
