Safety analysis of pemigatinib leveraging the US Food and Drug administration adverse event reporting system

被引:9
|
作者
Zhang, Ying [1 ]
Ran, Li [1 ]
Liang, Yongchao [1 ]
Zhang, Yanqiu [1 ]
An, Zhuoling [1 ]
机构
[1] Capital Med Univ, Beijing Chao Yang Hosp, Dept Pharm, Beijing, Peoples R China
关键词
pemigatinib; Food and Drug Administration adverse event reporting system; disproportionality analysis; real-word study; Advers drug events; PHASE-II; METASTATIC CHOLANGIOCARCINOMA; PATIENTS PTS; OPEN-LABEL; IN-VIVO; HYPOPHOSPHATEMIA; MULTICENTER; EXPRESSION; INHIBITORS; BGJ398;
D O I
10.3389/fphar.2023.1194545
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Background: Cholangiocarcinoma (CCA) is a highly lethal and aggressive epithelial tumor of the hepatobiliary system. A poor prognosis, propensity for relapse, low chance of cure and survival are some of its hallmarks. Pemigatinib, the first targeted treatment for CCA in the United States, has been demonstrated to have a significant response rate and encouraging survival data in early-phase trials. The adverse events (AEs) of pemigatinib must also be determined.Objective: To understand more deeply the safety of pemigatinib in the real world through data-mining of the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).Methods: Disproportionality analysis was employed in a retrospective pharmacovigilance investigation to identify the AEs linked to pemigatinib use as signals. Data were collected between 1 January 2020 to 30 June 2022. Four data-mining methods (proportional reporting odds ratio; proportional reporting ratio; Bayesian confidence propagation neural networks of information components; empirical Bayes geometric means) were used to calculate disproportionality.Results: A total of 203 cases using pemigatinib as the prime-suspect medication were found in our search, which involved 99 preferred terms (PTs). Thirteen signals of pemigatinib-induced AEs in seven System Organ Classes were detected after confirming the four algorithms simultaneously. Nephrolithiasis was an unexpected significant AE not listed on the drug label found in our data-mining. Comparison of the differences between pemigatinib and platinum drugs in terms of 33 PTs revealed that 13 PTs also met the criteria of the four algorithms. Ten of these PTs were identical to those compared with all other drugs, in which (excluding a reduction in phosphorus in blood) other PT signal values were higher than those of all other drugs tested. However, comparison of the differences between pemigatinib and infigratinib in terms of the 33 PTs revealed no significant signals in each algorithm method.Conclusion: Some significant signals were detected between pemigatinib use and AEs. PTs with apparently strong signals and PTs not mentioned in the label should be taken seriously.
引用
收藏
页数:15
相关论文
共 50 条
  • [41] Safety of Marketed Cancer Supportive Care Biosimilars in the US: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database
    Kaniz Afroz Tanni
    Cong Bang Truong
    Sura Almahasis
    Jingjing Qian
    BioDrugs, 2021, 35 : 239 - 254
  • [42] Reporting of drug reaction with eosinophilia and systemic symptoms from 2002 to 2019 in the US Food and Drug Administration Adverse Event Reporting System
    Bluestein, Sara Beth
    Yu, Roger
    Stone, Cosby, Jr.
    Phillips, Elizabeth J.
    JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE, 2021, 9 (08): : 3208 - +
  • [43] Analysis of anticholinergic adverse effects using two large databases: The US Food and Drug Administration Adverse Event Reporting System database and the Japanese Adverse Drug Event Report database
    Nagai, Junko
    Ishikawa, Yoichi
    PLOS ONE, 2021, 16 (12):
  • [44] An assessment of drug-induced rhabdomyolysis cases within the US Food and Drug Administration Adverse Event Reporting System
    Bin Dayel, Faten
    Alfirevic, Ana
    Turner, Richard
    Chadwick, Amy
    BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 2021, 87 (03) : 1617 - 1618
  • [45] 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.
    Drugs - Real World Outcomes, 2018, 5 (2) : 117 - 128
  • [46] Analysis of Duloxetine-Related Adverse Events Using the Food and Drug Administration Adverse Event Reporting System
    Zhu, Meng
    Lv, Shengxia
    Zhu, Feiye
    Zhang, Yongsheng
    JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY, 2025, 45 (02) : 96 - 105
  • [47] Differences in Hypersensitivity Reactions to Iodinated Contrast Media: Analysis of the US Food and Drug Administration Adverse Event Reporting System Database
    Lin, Xiuxian
    Yang, Jianhui
    Weng, Lizhu
    Lin, Wanlong
    JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE, 2023, 11 (05): : 1494 - +
  • [48] 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
    INTERNATIONAL JOURNAL OF CLINICAL PHARMACY, 2023, 45 (03) : 622 - 629
  • [49] 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
    International Journal of Clinical Pharmacy, 2023, 45 : 622 - 629
  • [50] Reporting of Drug-Induced Myopathies Associated with the Combination of Statins and Daptomycin: A Disproportionality Analysis Using the US Food and Drug Administration Adverse Event Reporting System
    Wei, Chunyan
    Yin, Wanhong
    He, Zhiyao
    Wu, Bin
    JOURNAL OF CLINICAL MEDICINE, 2023, 12 (10)