Study on the risk signal mining related to romiplostim based on the US Food and Drug Administration Adverse Event Reporting System
10.3760/cma.j.cn114015-20221008-00893
- VernacularTitle:基于美国FDA不良事件报告数据库的罗普司亭风险信号挖掘
- Author:
Zhangjiuzhi ZHOU
1
;
Leping MA
;
Wei ZHANG
;
Zhaoxue LI
Author Information
1. 石河子大学医学院第一附属医院药学部，石河子 832000
- Publication Type:Journal Article
- Keywords:
Adverse drug reaction reporting system;
Drug-related side effects and adverse reactions;
Signal processing, computer-assisted;
Romiplostim
- From:
Adverse Drug Reactions Journal
2023;25(3):165-171
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the adverse event (AE) risk signals of romiplostim, and provide reference for the safe use of the drug in clinic.Methods:The adverse event reports on romiplostim included in the US FDA Adverse Event Reporting System from the first quarter of 2008 to the second quarter of 2022 were collected. AEs were standardized using preferred term (PT) in the Medical Dictionary for Regulatory Activities. The general situation of patients and the outcome of AEs were extracted from the AE reports and analyzed descriptively and statistically. The AE risk signals of romiplostim was explored using the reporting odds ratio ( ROR) method and the proportional reporting odds ratio ( PRR) 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 and PRR were greater than 1. Results:A total of 12 222 AE reports with romiplostim as the primary suspected drug were collected. Among the 12 222 patients involved, 10 295 had gender records, including 4 818 males and 5 477 females; 3 789 patients with age records, ranging from 0 to 98 years, with an average age of 58 years; 5 919 patients with AE outcome records, the patient number of hospitalizations, death, life-threatening, disabling, and congenital malformation due to AEs were 3 092, 2 305, 363, 152, and 7, respectively. Twelve thousand two hundred and twenty-two AE reports involved 2 090 PTs, which occurred 20 639 times. Signal mining was performed on the top 100 PTs in the number of reports and 42 positive signals were detected. The top 5 PTs in the number of AE reports were decreased platelet count (PLT) (1 510 patients), lack of efficacy (1 488 patients), decreased efficacy (921 patients), abnormal PLT (857 patients), and death (853 patients). The PTs with signal intensity ranking in the top 5 were bone marrow reticulin fibrosis ( ROR=631.43, PRR=341.43), abnormal bone marrow biopsy ( ROR=202.73, PRR=159.36), abnormal platelet count ( ROR=200.90, PRR=159.49), splenectomy ( ROR=118.82, PRR=102.55) and thrombocytosis ( ROR=84.66, PRR=76.14). There were 10 PTs not recorded in the drug instruction, whose signal intensity from high to low in the order were splenectomy, chronic lymphocytic leukemia, hemolysis, hospitalization, pleural effusion, sepsis, bone pain, off-label drug use, hemoglobin reduction, and migraine. Conclusions:Bone marrow reticulin fibrosis and abnormal platelet count, as well as the resulting bleeding and thrombotic complications, are the AEs that need to be monitored during the use of romiplostim. Among the 10 PTs not recorded in the drug instruction, pleural effusion and sepsis need to be noticed.
