Association of anxiolytic drugs with Torsade de Pointes: a pharmacovigilance study of the Food and Drug Administration Adverse Event Reporting System

被引:1
作者
Ali, Zahid [1 ]
Ismail, Mohammad [1 ]
Rehman, Inayat Ur [2 ,3 ]
Goh, Khang Wen [4 ]
Razi, Pakhrur [5 ]
Ming, Long Chiau [6 ]
机构
[1] Univ Peshawar, Dept Pharm, Peshawar 25120, Khyber Pakhtunk, Pakistan
[2] Abdul Wali Khan Univ, Dept Pharm, Mardan, Pakistan
[3] Univ Malaya, Dept Clin Pharm & Pharm Practice, Kuala Lumpur, Malaysia
[4] INTI Int Univ, Fac Data Sci & Informat Technol, Nilai, Malaysia
[5] Univ Negeri Padang, Ctr Disaster Monitoring & Earth Observat, Phys Dept, Padang 25131, West Sumatra, Indonesia
[6] Sunway Univ, Sch Med & Life Sci, Sunway City, Malaysia
关键词
Medicine; human and disease; drug safety; patient safety; Patient Safety; preventable death; cardiology; cardiovascular disease; disproportionality analysis; pharmacovigilance; QT INTERVAL PROLONGATION; RISK-FACTORS; PREVENTION; BROMAZEPAM; GENDER;
D O I
10.1080/20523211.2024.2399716
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
Background:This study aimed to determine the association of Torsade de Pointes (TdP) with anxiolytic drugs and present a detailed overview of anxiolytic-induced cases of TdP reported to the Food and Drug Administration Adverse Event Reporting System (FAERS).Methods:All cases of anxiolytic-induced TdP (n = 260) between 1990 and 2020 were retrieved from the FAERS database using the Preferred Term 'Torsade de Pointes, code: 10044066' from the Medical Dictionary for Regulatory Activities (MedDRA version 22). Four data-mining algorithms were used for disproportionality analysis: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Empirical Bayes Geometric Mean (EBGM), and Information Content (IC). Anxiolytics with >= 3 TdP cases were included.Results:Of a total of eight drugs, this study identified seven signals of TdP, of which six signals were new, namely for alprazolam, bromazepam, lorazepam, meprobamate, midazolam, and oxazepam. Based on disproportionality analysis, among new signals, the highest risk of TdP was observed with bromazepam and midazolam. Alprazolam showed the lowest risk for TdP, while diazepam did not reach significant disproportionality.Conclusions:This study identified six new signals of TdP among anxiolytic drugs, so warranting stringent clinical studies to ascertain the actual risk of TdP and ensure patient safety.Clinical Trial Registration:This study is registered at ClinicalTrials.gov (NCT.gov ID: NCT04293432).
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页数:16
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