Zahid Ali, Mohammad Ismail, Inayat Ur Rehman, Khang Wen Goh, Pakhrur Razi, Long Chiau Ming
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). © 2024 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
Department of Pharmacy, University of Peshawar, Peshawar, Pakistan; Department of Pharmacy, Abdul Wali Khan University, Mardan, Pakistan; Department of Clinical Pharmacy and Pharmacy Practice, Universiti Malaya, Malaysia; Faculty of Data Science and Information Technology, INTI International University, Nilai, Malaysia; Center of Disaster Monitoring and Earth Observation, Physics Department, Universitas Negeri Padang, Padang, Indonesia; School of Medical and Life Sciences, Sunway University, Sunway City, Malaysia
