Signal mining of adverse events related to erenumab based on the US FDA Adverse Event Reporting System database
10.3760/cma.j.cn114015-20231121-00829
- VernacularTitle:基于美国FDA不良事件报告系统数据库的依瑞奈尤单抗风险信号挖掘
- Author:
Wenfang SUN
1
;
Binbin XIA
1
;
Hua CHENG
1
Author Information
1. 首都医科大学附属北京潞河医院药学部，北京 101149
- Publication Type:Journal Article
- Keywords:
Adverse drug reaction reporting systems;
Migraine disorders;
Calcitonin gene-related peptide;
Calcitonin gene-related peptide receptor antagonists;
Erenum
- From:
Adverse Drug Reactions Journal
2024;26(2):87-92
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To mine and analyze the signals of the adverse event (AE) of erenumab and provide reference for the safe application of the drug.Methods:The reports of AE from 2004 to the first quarter of 2023 were extracted from the US FDA Adverse Event Reporting System database, and the full data and data after 2018 were analyzed respectively. AEs were classified according to preferred term (PT) and the system organ class (SOC) of Medical Dictionary for Regulatory Activities (MedDRA) 23.0 version for statistical analysis. The reported odds ratio (ROR) method and Bayesian confidence progressive neural network (BCPNN) method were used to mine the AE risk signals.Results:A total of 38 348 AE reports with erenumab as the primary suspect drug were collected, involving 2 629 PTs. The number of risk signals screened by the ROR and BCPNN methods from the full data and data after 2018 was 99 and 115, respectively, involving 19 SOCs. Among them, the most frequently reported AEs were injection site reactions and constipation, which were consistent with the label. Among the top 30 PTs, 13 were not recorded in the label, including pineal cyst, postural tachycardia, positive histone antibody, spastic eye movements, fear of injection, post-concussion syndrome, Raynaud effect, psychogenic seizures, coronary artery dissection, premature menopause, trichorrhexis, collagen disease, and blepharospasm.Conclusion:In clinical application of erenumab, in addition to the adverse reactions recorded in the label, attention should also be paid to the adverse events mined in this study.
