Signal detection and analysis of the adverse events of ustekinumab based on OpenFDA database
- VernacularTitle:基于OpenFDA数据库的乌司奴单抗不良事件信号检测与分析
- Author:
Ting XU
1
;
Huiqing CHEN
1
Author Information
1. Dept. of Pharmacy，the Second Affiliated Hospital of Guangzhou University of Chinese Medicine，Guangzhou 510120，China
- Publication Type:Journal Article
- Keywords:
ustekinumab;
OpenFDA;
adverse events;
data mining
- From:
China Pharmacy
2023;34(2):185-189
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To analyze the risk of adverse drug reaction of ustekinumab， so as to provide reference for rational drug use in clinic. METHODS The adverse events （AE） reports related to ustekinumab included in the FDA public data program （OpenFDA） database were analyzed after marketing （from September 25th 2009 to December 30th 2021）. The risk signals were mined for top 100 AE by the method of reporting odds ratio （ROR） and proportional reporting ratio （PRR）. RESULTS A total of 62 356 AE reports related to ustekinumab were retrieved， male patients （51.79%） were more than female patients （39.51%）. Results of ROR method and PRR method showed that 31 suspicious signals were mined， mainly infections and infectious diseases （9 kinds）， general disorders and administration site conditions （5 kinds）， skin and subcutaneous tissue disorders diseases （4 kinds）， musculoskeletal and connective tissue disorders （4 kinds）， etc. Fourteen suspicious signals were not included in the instructions， such as hepatic enzyme increase， basal cell carcinoma， pericarditis， pemphigus， hair loss， synovitis， glossodynia， etc. CONCLUSIONS During clinical dosing of ustekinumab， in addition to ADR mentioned in package inserts， great attention should be paid to the patient’s liver function， skin status， hair loss and cardiovascular-related risks，which is helpful to discover AE early and ensure the safety medication of patients.
