Study on the risk signal mining of psychiatric disorders related to perampanel based on the US FDA Adverse Event Reporting System
10.3760/cma.j.cn114015-20220407-00296
- VernacularTitle:基于美国FDA不良事件报告数据库的吡仑帕奈精神不良反应风险信号挖掘
- Author:
Zhongsheng GU
1
;
Chunmei JI
1
Author Information
1. 江苏省人民医院（南京医科大学第一附属医院）药学部，南京 210029
- Publication Type:Journal Article
- Keywords:
Adverse drug reaction reporting system;
Drug-related side effects and adverse reactions;
Data analysis;
Perampanel
- From:
Adverse Drug Reactions Journal
2022;24(12):647-651
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the adverse reaction risk signals of perampanel-related psychiatric disorders, and provide reference for the clinical safe application of perampanel.Methods:The US FDA Adverse Event Reporting System database was searched, and the adverse event (AE) reports on psychiatric disorders from the third quarter of 2012 to the third quarter of 2021, which judged perampanel as the primary suspect drug were collected. The expression of AE was standardized using the preferred term (PT) in the Medical Dictionary for Regulatory Activities. Data such as patient general condition and psychiatric AE outcomes was extracted from AE reports and was analyzed descriptively. Risk signal mining for psychiatric adverse reactions to perampanel was performed using the reporting odds ratio ( ROR) method. The positive signal PT was set as that the number of AE reports was 3 and more and the lower limit of the 95% confidence interval ( CI) of the ROR was greater than 1. Results:A total of 922 reports on psychiatric AE with perampanel as the primary suspect drug were collected. Of the 922 patients involved, 439 were male, 441 were female, and 42 were unknown in gender. Age were recorded in 676 patients, and the age was (38±19) years. AE outcomes were recorded in 807 patients, of which hospitalization/prolonged hospitalization, urgent treatment needs, life threatening, and death due to AE occurred respectively in 409 (44.4%), 316 (34.3%), 60 (6.5%) and 22 patients (2.4%). The 922 AEs involved 1 580 PTs, and 46 PTs were detected with positive signals by ROR method. The top 5 PTs mostly reported were aggression (286 AEs), irritability (128 AEs), suicidal ideation (110 AEs), suicide attempt (100 AEs), and anger (77 AEs). The top 5 PTs with strongest signal intensity ( ROR value) were postictal psychosis (383.13), schizophreniform disorder (355.27), homicidal ideation (203.56), dissociative disorder (119.64) and delusional perception (108.34), among which dissociative disorder and postictal psychosis were AEs not recorded in the drug labels. In the 46 PTs with positive signal, 14 (30.4%) were not recorded in the drug labels, and the other 12 PTs were listed as sexually inappropriate behaviour (81.43), suspiciousness (65.20), disinhibition (32.72), impulsive behaviour (31.18), personality change (22.56), abnormal behaviour (16.31), social avoidant behaviour (12.95), restlessness (6.15), bipolar disorder (5.23), affect lability (5.09), nightmare es (2.86), and fear (2.79). Conclusion:psychiatric adverse reaction is a common and serious adverse reaction of perampanel, which should be paid attention to clinically.
