Analysis of safety difference of 10 kinds of commonly used anti-infective agents with same generic drugs name based on the adverse drug reaction data
10.3760/cma.j.issn.1008-5734.2017.05.005
- VernacularTitle:基于药物不良反应数据分析10种常用抗感染药物的相同通用名药物安全性的差异
- Author:
Ye TIAN
1
;
Muyu ZHANG
;
Sheng HAN
;
Xiaodong GUAN
;
Wujie ZOU
;
Jinxin SHANG
;
Luwen SHI
Author Information
1. 100191,北京大学药学院药事管理与临床药学系
- Publication Type:Journal Article
- Keywords:
Anti-infective agents;
Safety;
Data interpretation;
statistical
- From:
Adverse Drug Reactions Journal
2017;19(5):340-345
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the possible safety difference of anti-infective agents with the same generic drug name produced by different manufacturers. Methods Spontaneous Reporting System for Adverse Drug Reactions of Beijing was searched. The reports of adverse drug reactions(ADR)of levofloxacin,azithromycin,moxifloxacin,clindamycin,cefuroxime,etimicin,cefoperazone sulbactam sodium,cefoxitin,ceftriaxone and ornidazole from January 2009 to December 2013 were collected. The number of ADR reports,types of ADR,suspicious drugs which induced ADR,and the manufacturers were recorded. The number of ADR signals was detected by reporting odds ratio(ROR)method. The safety of drugs was evaluated according to the number of signal and the type of ADR. Results A total of 18 366 ADR reports of 10 kinds of anti-infective drugs were collected. The top five ADR′s types were skin and subcutaneous tissue diseases(7 644),gastrointestinal diseases(2 505),systemic diseases and various parts of the site of treatment(1 761),nervous system disease(1 592)and immune system diseases (1 254)successively. The sum of the digits above accounted for 80.3% in total number of 10 kinds of anti-infective drugs ADR reports(14 756/18 366). The drugs which caused the five kinds of ADR were levofloxacin,azithromycin and clindamycin/moxifloxacin mainly. The numbers of ADR signals of evofloxacin,azithromycin,moxifloxacin,clindamycin,cefuroxime,etimicin,cefoperazone sulbactam sodium,cefoxitin,ceftriaxone,and ornidazole which were detected by ROR method were 17,20,1,23,9, 9,20,5,1 and 9,respectively. The ADR types related to ADR signals were 11,12,1,12,6,8,10,5 and 8,respectively. The numbers of manufacturers related to ADR signals were 9,13,1,14,6,9,11,5, 1 and 9,respectively. Conclusions There are some differences in ADR signals and ADR types among the 10 kinds of anti-infective agents with the same generic drug name produced by different manufacturers. It is suggested that there are some differences in safety of the above-mentioned drugs.
