Related Experiment Video

Updated: Mar 29, 2026

Determining the Likelihood of Variant Pathogenicity Using Amino Acid-level Signal-to-Noise Analysis of Genetic Variation
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Determining the Likelihood of Variant Pathogenicity Using Amino Acid-level Signal-to-Noise Analysis of Genetic Variation

Published on: January 16, 2019

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Drug-associated torsades de pointes and QT prolongation in infants: A focused real-world disproportionality analysis

Kannan Sridharan1, Gowri Sivaramakrishnan2

  • 1Department of Pharmacology & Therapeutics, College of Medicine & Health Sciences, Arabian Gulf University, Manama, Kingdom of Bahrain.

Pediatrics and Neonatology
|March 27, 2026
PubMed

Insights

This study identified drugs like fentanyl, propofol, and erythromycin linked to Torsades de Pointes (TdP) and QT prolongation in infants. Vigilant monitoring is crucial for infant drug safety.

Area of Science:

  • Pharmacovigilance
  • Pediatric Drug Safety
  • Cardiology

Background:

  • Torsades de Pointes (TdP) is a dangerous heart rhythm linked to QT prolongation.
  • Infant risk factors and drug associations for TdP are not well understood.
  • Infants are particularly vulnerable to adverse drug reactions.

Purpose of the Study:

  • To identify drugs associated with TdP and QT prolongation in infants.
  • To analyze data from the USFDA Adverse Event Reporting System (AERS).

Main Methods:

  • Disproportionality analysis of USFDA AERS data.
  • Used Standardized MedDRA Narrow Query (SMQ) for TdP/QT prolongation.
  • Applied frequentist and Bayesian statistical methods for signal detection.

Main Results:

  • Identified significant drug signals for TdP and QT prolongation in infants.
  • Associated drugs include anesthetics (fentanyl, propofol), antibacterials (erythromycin, azithromycin), and cardiac meds (propranolol, amiodarone).
  • Midazolam strongly linked to long QT syndrome; 8.5% of reports resulted in death.

Conclusions:

  • Highlights critical drug safety signals for TdP and QT prolongation in infants.
  • Emphasizes the need for vigilant monitoring and cautious drug use in pediatric populations.
  • Calls for further research to improve pediatric pharmacovigilance.
Abstract

Keywords:
InfantsNeonatesQT prolongationTdPUSFDA AERS

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