Mining of the risk signal for ocular adverse events related to mycophenolate mofetil based on the US FDA Adverse Event Reporting System database
10.3760/cma.j.cn114015-20230417-00277
- VernacularTitle:基于美国FDA不良事件报告系统数据库的吗替麦考酚酯相关眼部不良事件风险信号挖掘
- Author:
Yang TANG
1
;
Yanbin MA
;
Shuyun WANG
;
Qian GUO
;
Donghong YIN
;
Jinju DUAN
Author Information
1. 山西医科大学药学院，太原 030001
- Publication Type:Journal Article
- Keywords:
Immunosuppressive agents;
Eye;
Drug toxicity;
Mycophenolate mofetil;
Adverse event signal detection;
Data mining;
Pharmacovigilance
- From:
Adverse Drug Reactions Journal
2023;25(11):662-668
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To understand the risk signal of ocular adverse events (AE) related to mycophenolate mofetil (MMF) and to provide reference for the safe clinical use of this drug.Methods:The US FDA Adverse Event Reporting System database was searched, and the AE reports on MMF as the primary suspect drug from the 1st quarter of 2004 to the 3rd quarter of 2022 were collected. AEs were counted and classified using the preferred system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities version 24.0, and ocular AEs were screened out. The ocular AE risk signals were explored using 3 frequency methods, including reporting odds ratio (ROR) method, proportional reporting ratio (PRR) method, and Bayesian confidence propagation neural network method, and the multi-item gamma-Possion shrinker (MGPS) method. The information of the ocular AE reports and AE risk signals of MMF were analyzed descriptively. Results:A total of 402 cases of ocular AE with MMF as the primary suspect drug were collected, which involved 402 patients, 31 PTs and 5 SOCs. The 402 AE cases were reported among 33 countries, 283 of which had clinical outcome records, including death in 32 cases (11.3%), disability or blindness in 142 cases (50.2%), life-threatening in 14 cases (4.9%), and hospitalization or prolonged hospitalization in 95 cases (33.6%). Results of the frequency method showed that all 31 PTs were risk signals, while the results of the MGPS method manifested that 22 PTs were risk signals. None of the 31 PTs were recorded in the drug labels. The top 5 PTs in the number of AE reports were blindness (136 cases), cytomegalovirus chorioretinitis (37 cases), uveitis (34 cases), endophthalmitis (29 cases), and necrotising retinitis (22 cases). The ranking of signal intensity showed by the 4 methods was similar. The top 5 PTs with the high signal intensity were orbital apex syndrome [ ROR=55.84, PRR=55.83, information component ( IC)=5.58, empirical Bayesian geometric mean ( EBGM)=47.71], quadrantanopia ( ROR=43.22, PRR=43.21, IC=5.26, EBGM=38.21), retinitis viral ( ROR=40.13, PRR=40.13, IC=5.16, EBGM=35.78), optic discs blurred ( ROR=40.13, PRR=40.13, IC=5.16, EBGM=35.78), and serpiginous choroiditis ( ROR=31.07, PRR=31.07, IC=4.83, EBGM=28.41). Conclusions:The clinical manifestations of ocular AE during MMF treatment are diverse, and none of them are recorded in the drug label. The clinical outcomes are poor and can lead to blindness, which should be vigilant in clinical practice.
