ArticleJournal of pharmaceutical policy and practice2024
Association of anxiolytic drugs with Torsade de Pointes: a pharmacovigilance study of the Food and Drug Administration Adverse Event Reporting System.
Article in Journal of pharmaceutical policy and practice, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04293432 (A Pharmacovigilance Study of Torsade de Pointes in the Food and Drug Administration Adverse Event Reporting System Using Data Mining Algorithms), which is not on this map. Cited by 2 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Pharmacovigilance Study of Torsade de Pointes in the Food and Drug Administration Adverse Event Reporting System Using Data Mining Algorithms
Who cites it
2 citing papers in PubMed.
- Proton Pump Inhibitors and Disproportionate Reporting of Acute Kidney Injury and Tubulointerstitial Nephritis: A FAERS Pharmacovigilance Study, 2020-2025.Journal of clinical medicine · 2026Article
- Comparison of safety of lecanemab and aducanumab: a real-world disproportionality analysis using the FDA adverse event reporting system.Frontiers in pharmacology · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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 ( 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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