Contrastive analysis on the safety of brand and generic nebivolol: a real-world pharmacovigilance study based on the FDA adverse event reporting system

作者全名："Wang, Hongli; Zhong, Guizun; Ji, Huanhuan; Chen, Siqi; Xie, Qinqin; Shen, Zhengze; Jia, Yuntao"

作者地址："[Wang, Hongli; Zhong, Guizun; Shen, Zhengze] Chongqing Med Univ, Yongchuan Hosp, Dept Pharm, Chongqing, Peoples R China; [Wang, Hongli; Zhong, Guizun; Chen, Siqi; Xie, Qinqin] Chongqing Med Univ, Coll Pharm, Chongqing, Peoples R China; [Ji, Huanhuan; Jia, Yuntao] Chongqing Med Univ, Natl Clin Res Ctr Child Hlth & Disorders, Key Lab Child Dev & Disorders,Childrens Hosp,Dept, Chongqing Key Lab Child Rare Dis Infect & Immun,Mi, Chongqing, Peoples R China"

通信作者："Shen, ZZ (通讯作者)，Chongqing Med Univ, Yongchuan Hosp, Dept Pharm, Chongqing, Peoples R China.; Jia, YT (通讯作者)，Chongqing Med Univ, Natl Clin Res Ctr Child Hlth & Disorders, Key Lab Child Dev & Disorders,Childrens Hosp,Dept, Chongqing Key Lab Child Rare Dis Infect & Immun,Mi, Chongqing, Peoples R China."

来源：FRONTIERS IN PHARMACOLOGY

ESI学科分类：PHARMACOLOGY & TOXICOLOGY

WOS号：WOS:001160378200001

JCR分区：Q1

影响因子：5.6

年份：2024

卷号：15

期号：　

开始页：　

结束页：　

文献类型：Article

关键词：nebivolol; original drug; generic drug; FDA adverse event reporting system; disproportional analysis; adverse reaction

摘要："Background: The equivalence of generic drugs to their brand-name counterparts is a controversial issue. Current literature indicates disparities between the generic nebivolol (GN) and the brand nebivolol (BN).Aim: The study is designed to investigate the safety difference between GN and BN and provide reference information for clinical practice.Methods: We reviewed adverse event (AE) reports that recorded nebivolol as the primary suspect drug in the FDA Adverse Event Reporting System (FAERS) database from 2004 to 2022, conducted a disproportional analysis to detect signals for the GN and BN respectively, and compared the AE heterogeneity between them using the Breslow-Day test.Results: A total of 2613 AE reports of nebivolol were recorded in the FAERS database from 2004 to 2022, of which 2,200 were classified as BN, 346 as GN, and 67 unclassifiable AE reports were excluded. The signals of 37 AEs distributed in cardiac, gastrointestinal, psychiatric, and nervous systems were detected in disproportional analysis. 33 out of 37 AEs were positive signals, with 21 not previously listed on the drug label, indicating an unrecognized risk with nebivolol. In the heterogeneity analysis of AE signals between GN and BN, the GN generally showed a higher AE signal value than BN, especially 15 AEs distributed in the cardiac, neurological, and psychiatric systems that showed statistically significantly higher risk by taking GN.Conclusion: Our study shows some previously overlooked adverse effects of nebivolol. It suggests that the risk of GN's adverse effects may be higher than those in BN, which deserves further attention and investigation by healthcare professionals, regulators, and others."

基金机构：Future Medicine Youth Innovation Team project of Chongqing Medical University [W0081]; Chongqing Clinical Pharmacy Key Specialty Construction Project; Key project of Chongqing Science and Health Joint Medical Scientific Research Project [2022ZDXM020]

基金资助正文："The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This work was supported by three fundings, namely, the Future Medicine Youth Innovation Team project of Chongqing Medical University (W0081), the Chongqing Clinical Pharmacy Key Specialty Construction Project, and the Key project of Chongqing Science and Health Joint Medical Scientific Research Project (2022ZDXM020)."