ArticleDrug safety2013
Antipsychotics and torsadogenic risk: signals emerging from the US FDA Adverse Event Reporting System database.
Article in Drug safety, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers.
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Who cites it
44 citing papers in PubMed.
- Disproportionality analysis and "perpetrator" or "accomplice" review of Baloxavir marboxil in public FAERS database.BMC infectious diseases · 2026Article
- QT-related adverse events with ondansetron and olanzapine: a real-world FAERS analysis with implications for oncology anti-emetic practice.Frontiers in pharmacology · 2026Article
- A pharmacovigilance study of olanzapine/samidorphan based on FDA Adverse Event Reporting System (FAERS).BMC pharmacology & toxicology · 2025Article
- Antipsychotic-Related DRESS Syndrome: Analysis of Individual Case Safety Reports of the WHO Pharmacovigilance Database.Drug safety · 2024Article
- Cardiac adverse events associated with quetiapine: Disproportionality analysis of FDA adverse event reporting system.CNS neuroscience & therapeutics · 2023Article
- Mapping Strategies to Assess and Increase the Validity of Published Disproportionality Signals: A Meta-Research Study.Drug safety · 2023Article
- Differences in circadian variation in QT interval of the ECG in women compared to men.American journal of cardiovascular disease · 2023Article
- Impulse Control Disorders by Dopamine Partial Agonists: A Pharmacovigilance-Pharmacodynamic Assessment Through the FDA Adverse Event Reporting System.The international journal of neuropsychopharmacology · 2022Article
- Drug-induced torsades de pointes: Disproportionality analysis of the United States Food and Drug Administration adverse event reporting system.Frontiers in cardiovascular medicine · 2022Article
- Mapping the Knowledge of Antipsychotics-Induced Sudden Cardiac Death: A Scientometric Analysis in CiteSpace and VOSviewer.Frontiers in psychiatry · 2022Article
- Cardiovascular Toxicity of Carfilzomib: The Real-World Evidence Based on the Adverse Event Reporting System Database of the FDA, the United States.Frontiers in cardiovascular medicine · 2021Article
- Characteristics and Spectrum of Cardiotoxicity Induced by Various Antipsychotics: A Real-World Study From 2015 to 2020 Based on FAERS.Frontiers in pharmacology · 2021Article
- Characteristics of voluntary reporting of adverse drug events related to antipsychotics in Australia: 14-year analysis.Therapeutic advances in drug safety · 2021Article
- Post marketing surveillance of suspected adverse drug reactions through spontaneous reporting: current status, challenges and the future.Therapeutic advances in drug safety · 2020Review
- The Role of European Healthcare Databases for Post-Marketing Drug Effectiveness, Safety and Value Evaluation: Where Does Italy Stand?Drug safety · 2019Review
- A simple method for exploring adverse drug events in patients with different primary diseases using spontaneous reporting system.BMC bioinformatics · 2018Article
- An evaluation of the Manufacturer And User Facility Device Experience database that inspired the United States Food and Drug Administration's Reclassification of transvaginal mesh.Investigative and clinical urology · 2018Article
- A New Search Method Using Association Rule Mining for Drug-Drug Interaction Based on Spontaneous Report System.Frontiers in pharmacology · 2018Article
- Management of serious cardiac adverse effects of antipsychotic medications.The mental health clinician · 2017Article
- Balancing the Need for Personalization of QT Correction and Generalization of Study Results: Going Beyond Thorough QT Studies.Clinical drug investigation · 2017Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDrug-induced torsades de pointes (TdP) and related clinical entities represent a current regulatory and clinical burden.
objectiveAs part of the FP7 ARITMO (Arrhythmogenic Potential of Drugs) project, we explored the publicly available US FDA Adverse Event Reporting System (FAERS) database to detect signals of torsadogenicity for antipsychotics (APs).
methodsFour groups of events in decreasing order of drug-attributable risk were identified: (1) TdP, (2) QT-interval abnormalities, (3) ventricular fibrillation/tachycardia, and (4) sudden cardiac death. The reporting odds ratio (ROR) with 95 % confidence interval (CI) was calculated through a cumulative analysis from group 1 to 4. For groups 1+2, ROR was adjusted for age, gender, and concomitant drugs (e.g., antiarrhythmics) and stratified for AZCERT drugs, lists I and II (http://www.azcert.org , as of June 2011). A potential signal of torsadogenicity was defined if a drug met all the following criteria: (a) four or more cases in group 1+2; (b) significant ROR in group 1+2 that persists through the cumulative approach; (c) significant adjusted ROR for group 1+2 in the stratum without AZCERT drugs; (d) not included in AZCERT lists (as of June 2011).
resultsOver the 7-year period, 37 APs were reported in 4,794 cases of arrhythmia: 140 (group 1), 883 (group 2), 1,651 (group 3), and 2,120 (group 4). Based on our criteria, the following potential signals of torsadogenicity were found: amisulpride (25 cases; adjusted ROR in the stratum without AZCERT drugs = 43.94, 95 % CI 22.82-84.60), cyamemazine (11; 15.48, 6.87-34.91), and olanzapine (189; 7.74, 6.45-9.30).
conclusionsThis pharmacovigilance analysis on the FAERS found 3 potential signals of torsadogenicity for drugs previously unknown for this risk.
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