Risk signal mining of adverse events of nervous system related to EGFR inhibitors based on FDA Adverse Events Reporting System database
10.3760/cma.j.cn114015-20231108-00783
- VernacularTitle:基于美国FDA不良事件报告系统数据库的EGFR抑制剂相关神经系统不良事件风险信号挖掘
- Author:
Yuan ZHENG
1
;
Chen YAN
1
;
Bin LI
1
;
Zhengxiang LI
1
;
Hengjie YUAN
1
Author Information
1. 天津医科大学总医院药剂科，天津 300052
- Publication Type:Journal Article
- Keywords:
Adverse drug reaction reporting system;
Drug-related side effects and adverse events;
Epidermal growth factor receptor inhibitors;
Nervous system-related
- From:
Adverse Drug Reactions Journal
2024;26(9):524-529
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To mine the adverse events (AE) of nervous system caused by epidermal growth factor receptor (EGFR) inhibitors, and provide reference for the safe use of EGFR inhibitors in clinics.Methods:AE of nervous system caused by gefitinib, erlotinib, afatinib and osimertinib were searched from FDA Adverse Drug Event Reporting System (FAERS) database using OpenVigil data platform from 2004, 2004, 2013, and 2015 to the 2nd quarter of 2023, respectively. The AE was standardized using the preferred term (PT) in the Medical Dictionary for Regulatory Activities 23.0 version. Data such as patient general condition and AE of nervous system was extracted from AE reports and was analyzed descriptively. Reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods were used for detection of AE signal of nervous system. AE that simultaneously met the following conditions was considered as a risk signal: the number of report cases ≥3, lower limit of the 95% confidence interval of ROR≥1, PRR≥2, and χ2≥4. Results:A total of 422 nervous system AE cases related to gifitinib were collected, involving 297 patients and 42 preferred terms (PT); 10 risk signals were detected, including dementia, brain oedema, demyelination, leukoencephalopathy, hemiplegia, vocal cord paralysis, neurological symptom, cerebral atrophy, intracranial pressure increase and neuropathy, with 64 AE cases involved. One thousand seven hundred and fifty-five nervous system AE cases related to erlotinib were collected, involving 1 477 patients and 69 PT; 7 risk signals were detected, including ageusia, hyperaesthesia, facial pain, demyelination, motion sickness, vocal cord paralysis, peripheral paralysis, with 142 AE cases involved. Two hundred and forty-seven nervous system AE cases related to afatinib were collected, involving 212 patients and 32 PT; 7 risk signals were detected, including ageusia, cerebral infarction, brain oedema, epilepsy, central nervous system lesion, leukoencephalopathy, cerebral disorder, with 49 AE cases involved. Six hundred and fifty-two nervous system AE cases related to osimertinib were collected, involving 582 patients and 46 PT; 3 risk signals were detected, including cerebral infarction, vocal cord paralysis, facial paralysis, with 54 AE cases involved. Ageusia was an AE already included in the label of afatinib, while other AE were not included.Conclusion:Most of the EGFR inhibitor-related AE signals found in the FAERS database are not included in the labels, and should be monitored during the clinical use.
