Detection and analysis of signals of adverse events of memantine based on the US food and drug administration adverse event reporting system

被引:0
|
作者
Zhang, Weichui [1 ]
Chen, Mianhai [1 ]
Cai, Xiaolin [1 ]
Zhang, Mengting [1 ]
Hu, Mianda [1 ]
Hu, Yanghui [1 ]
Yang, Yurong [1 ]
Zhu, Jinfeng [1 ]
Du, Yikuan [2 ]
Yang, Chun [1 ]
机构
[1] Guangdong Med Univ, Dongguan Key Lab Stem Cell & Regenerat Tissue Engn, Songshan Lake Sci & Technol Pk, Dongguan 523808, Peoples R China
[2] Southern Med Univ, Affiliated Hosp 10, Cent Lab, San Ku Chong Wan Rd, Dongguan 523059, Peoples R China
关键词
Adverse effects; FAERS; memantine; pharmacovigilance; signal mining; ALZHEIMERS-DISEASE; INDUCED MYOCLONUS; EFFICACY; HYPOGLYCEMIA; BRADYCARDIA; SECRETION; PATIENT; SAFETY;
D O I
10.1080/14740338.2024.2338251
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
BackgroundDespite its widespread use, the adverse effects (AEs) of memantine have not been well documented, and there is a need to find new ways to analyze the AEs of memantine.Research design and methodsAEs in which the primary suspected drug was memantine were retrieved from the FAERS database. The proportional report ratio (PRR), reporting odds ratio (ROR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayesian geometric mean (EBGM) were used to detect potential positive signals between memantine and AEs. SAS, MySQL, EXCEL, and R language software were used for data processing and statistical analysis.ResultsThis study gathered a total of 5808 reports of AEs associated with memantine. Of these reports, a greater proportion of female patients (51.17%) than male patients (36.33%) had AEs. The AEs reported by FAERS were mainly in psychiatric category (n = 2157, IC025 = 2.69), various neurologic disorders (n = 1608, IC025 = 2.04), systemic disorders and various site reactions (n = 842, IC025 = 1.29). Unexpected ocular adverse events have been reported, ophthalmic vein thrombosis (n = 4, IC025 = 3.47) and scleral discolouration (n = 7, IC025 = 3.1), which may worsen glaucoma.ConclusionsThis study observed conceivable new AEs signals and may supply important assist for scientific monitoring and threat identification of memantine.
引用
收藏
页码:617 / 625
页数:9
相关论文
共 50 条
  • [1] Adverse events reported to the US Food and Drug Administration Adverse Event Reporting System for tisagenlecleucel
    Dores, Graca M.
    Jason, Christopher
    Niu, Manette T.
    Perez-Vilar, Silvia
    [J]. AMERICAN JOURNAL OF HEMATOLOGY, 2021, 96 (09) : 1087 - 1100
  • [2] Data mining and analysis for emicizumab adverse event signals based on the Food and Drug Administration Adverse Event Reporting System database
    Wei, Lianhui
    Tian, Ye
    Chen, Xiao
    Guo, Xiaojing
    Chen, Chenxin
    Zheng, Yi
    Xu, Jinfang
    Ye, Xiaofei
    [J]. INTERNATIONAL JOURNAL OF CLINICAL PHARMACY, 2023, 45 (03) : 622 - 629
  • [3] Data mining and analysis for emicizumab adverse event signals based on the Food and Drug Administration Adverse Event Reporting System database
    Lianhui Wei
    Ye Tian
    Xiao Chen
    Xiaojing Guo
    Chenxin Chen
    Yi Zheng
    Jinfang Xu
    Xiaofei Ye
    [J]. International Journal of Clinical Pharmacy, 2023, 45 : 622 - 629
  • [4] Mortality and adverse events with brand and generic clopidogrel in the US Food and Drug Administration Adverse Event Reporting System
    Serebruany, Victor L.
    Hall, Trygve S.
    Atar, Dan
    Agewall, Stefan
    Kim, Moo Hyun
    Geudelin, Bernard
    Lomakin, Nikita
    Marciniak, Thomas A.
    [J]. EUROPEAN HEART JOURNAL-CARDIOVASCULAR PHARMACOTHERAPY, 2019, 5 (04) : 210 - 215
  • [5] Novel Adverse Events of Iloperidone: A Disproportionality Analysis in US Food and Drug Administration Adverse Event Reporting System (FAERS) Database
    Subeesh, Viswam
    Maheswari, Eswaran
    Singh, Hemendra
    Beulah, Thomas Elsa
    Swaroop, Ann Mary
    [J]. CURRENT DRUG SAFETY, 2019, 14 (01) : 21 - 26
  • [6] Data mining and analysis of the adverse events derived signals of 4 gadolinium-based contrast agents based on the US Food and drug administration adverse event reporting system
    Wang, Lu
    Wang, Yinglin
    Zhao, Quan
    [J]. EXPERT OPINION ON DRUG SAFETY, 2024, 23 (03) : 339 - 352
  • [7] Analysis of Information on Drug Adverse Reactions Using US Food and Drug Administration Adverse Event Reporting System (FAERS)
    Nango, Daisuke
    Sekizuka, Tuyoshi
    Goto, Makoto
    Echizen, Hirotoshi
    [J]. YAKUGAKU ZASSHI-JOURNAL OF THE PHARMACEUTICAL SOCIETY OF JAPAN, 2022, 142 (04): : 341 - 344
  • [8] A pharmacovigilance study of adverse events associated with polymyxins based on the US Food and Drug Administration Adverse Event Reporting System (FAERS) database
    Wu, Tingxi
    Shi, Yanfeng
    Xu, Chang
    Zhu, Bin
    Li, Dandan
    Li, Zhe
    Zhao, Zhigang
    Zhang, Yang
    [J]. EXPERT OPINION ON DRUG SAFETY, 2024,
  • [9] Spontaneous Reporting on Adverse Events by Consumers in the United States: An Analysis of the Food and Drug Administration Adverse Event Reporting System Database
    Toki T.
    Ono S.
    [J]. Drugs - Real World Outcomes, 2018, 5 (2) : 117 - 128
  • [10] Reporting Cosmetic Adverse Events to the US Food and Drug Administration
    Katz, Linda M.
    Valenzuela, Claudia
    Sadrieh, Nakissa K.
    [J]. DERMATITIS, 2016, 27 (04) : 236 - 237