The futility of adverse drug event reporting systems for monitoring known safety issues: A case study of myocardial infarction with rofecoxib and other drugs

被引：2
|
作者：
Haguinet, Francois [1 ]
Bate, Andrew [2 ,3 ]
Stegmann, Jens-Ulrich [1 ]
机构：
[1] GSK, Global Safety, Wavre, Belgium
[2] GSK, Global Safety, Brentford, England
[3] London Sch Hyg & Trop Med, Dept Noncommunicable Dis Epidemiol, London, England
来源：
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY | 2024年 / 33卷 / 01期
关键词：
labeled adverse events; myocardial infarction; pharmacovigilance; real-world data; rofecoxib; Sentinel; spontaneous reporting system; FOOD;
D O I：
10.1002/pds.5719
中图分类号：
R1 [预防医学、卫生学];
学科分类号：
1004 ; 120402 ;
摘要：
引用
收藏
页数：5
相关论文
共 46 条
  • [1] An analysis of the safety of Sevoflurane drugs: A disproportionality analysis based on Food and Drug Administration Adverse Event Reporting System
    Yang, Xinxia
    Shen, Yiming
    Chen, Hang
    Chen, Dongdong
    MEDICINE, 2024, 103 (35)
  • [2] Association Between Antidiabetic Drugs and Delirium: A Study Based on the Adverse Drug Event Reporting Database in Japan
    Yukiko Ishibashi
    Rintaro Sogawa
    Kenji Ogata
    Ayaka Matsuoka
    Haruna Yamada
    Toru Murakawa-Hirachi
    Yoshito Mizoguchi
    Akira Monji
    Chisato Shimanoe
    Clinical Drug Investigation, 2024, 44 : 115 - 120
  • [3] Comparing Time to Adverse Drug Reaction Signals in a Spontaneous Reporting Database and a Claims Database: A Case Study of Rofecoxib-Induced Myocardial Infarction and Rosiglitazone-Induced Heart Failure Signals in Australia
    Wahab, Izyan A.
    Pratt, Nicole L.
    Kalisch, Lisa M.
    Roughead, Elizabeth E.
    DRUG SAFETY, 2014, 37 (01) : 53 - 64
  • [4] Comparing Time to Adverse Drug Reaction Signals in a Spontaneous Reporting Database and a Claims Database: A Case Study of Rofecoxib-Induced Myocardial Infarction and Rosiglitazone-Induced Heart Failure Signals in Australia
    Izyan A.Wahab
    Nicole L. Pratt
    Lisa M. Kalisch
    Elizabeth E. Roughead
    Drug Safety, 2014, 37 : 53 - 64
  • [5] Analysis of individual case safety reports of drug-induced anaphylaxis to the Korea Adverse Event Reporting System
    Cho, Min Kyoung
    Moon, Mira
    Kim, Hyun Hwa
    Kang, Dong Yoon
    Lee, Ju-Yeun
    Cho, Sang-Heon
    Kang, Hye-Ryun
    ALLERGY ASTHMA & RESPIRATORY DISEASE, 2020, 8 (01): : 30 - 35
  • [6] Safety Analysis of Adverse Drug Reactions in United States: A 21-Year descriptive Study of FDA Adverse Event Reporting System
    Chalabianlo, Niaz
    Ahmadi, Fatemeh
    Abdullah, Sheikh
    Sedig, Kamran
    Muanda, Flory Tsobo
    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2024, 33 : 307 - 308
  • [7] Clinical adverse events to letairis: a real-world drug safety study based on FDA Adverse Event Reporting System (FAERS)
    Bi, Yu-Ting
    Dong, Bo
    EXPERT OPINION ON DRUG SAFETY, 2024,
  • [8] Association of anxiolytic drugs with Torsade de Pointes: a pharmacovigilance study of the Food and Drug Administration Adverse Event Reporting System
    Ali, Zahid
    Ismail, Mohammad
    Rehman, Inayat Ur
    Goh, Khang Wen
    Razi, Pakhrur
    Ming, Long Chiau
    JOURNAL OF PHARMACEUTICAL POLICY AND PRACTICE, 2024, 17 (01)
  • [9] Post-Marketing Safety of Temozolomide: A Pharmacovigilance Study Based on the Food and Drug Administration Adverse Event Reporting System
    Lin, Yuhao
    Deng, Muling
    Xu, Siqi
    Chen, Chuanben
    Ding, Jianming
    ONCOLOGY, 2025,
  • [10] Adverse events of nusinersen: a real-world drug safety surveillance study based on the FDA adverse event reporting system (FAERS) database
    Zhang, Xiaofang
    Gui, Jianxiong
    Wang, Lingman
    Jiang, Chunxue
    Ding, Ran
    Meng, Linxue
    Hong, Siqi
    Jiang, Li
    EXPERT OPINION ON DRUG SAFETY, 2024,
12345