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Torsades de pointes and QT prolongation Associations with Antibiotics: A Pharmacovigilance Study of the FDA Adverse

Chengwen Teng1,2, Elizabeth A Walter3,4,5, Daryl Kevin S Gaspar1,2

  • 1Pharmacotherapy Division, College of Pharmacy, The University of Texas at Austin, San Antonio, TX, USA.

International Journal of Medical Sciences
|July 26, 2019
PubMed

Insights

This study found macrolides and linezolid are strongly linked to Torsades de pointes/QT prolongation (TdP/QTP). It also identified amikacin as a new potential risk for TdP/QTP among antibiotics.

Area of Science:

  • Pharmacovigilance
  • Cardiology
  • Infectious Diseases

Background:

  • Torsades de pointes/QT prolongation (TdP/QTP) is a serious cardiac arrhythmia.
  • Several antibiotic classes, including macrolides and fluoroquinolones, are known TdP/QTP risks.
  • A systematic comparison of TdP/QTP risks across numerous antibiotics is lacking.

Purpose of the Study:

  • To evaluate the association between various antibiotics and TdP/QTP.
  • To utilize the FDA Adverse Event Report System (FAERS) for comprehensive analysis.

Main Methods:

  • Analysis of FAERS data from January 1, 2015, to December 31, 2017.
  • Identification of TdP/QTP cases using the Medical Dictionary for Regulatory Activities (MedDRA).
  • Calculation of Reporting Odds Ratios (RORs) with 95% confidence intervals (95%CI) to assess antibiotic-TdP/QTP associations.

Main Results:

  • Macrolides exhibited the highest proportion of TdP/QTP reports (2.6%).
  • Significant TdP/QTP associations (RORs [95%CI]) were found for macrolides (14.32 [11.80-17.38]), linezolid (12.41 [8.52-18.08]), amikacin (11.80 [5.57-24.97]), imipenem-cilastatin (6.61 [3.13-13.94]), fluoroquinolones (5.68 [4.78-6.76]), penicillin combinations (3.42 [2.35-4.96]), and ceftriaxone (2.55 [1.41-4.62]).
  • A novel association between amikacin and TdP/QTP was identified.

Conclusions:

  • Study confirms known TdP/QTP risks for macrolides, linezolid, imipenem-cilastatin, fluoroquinolones, penicillin combinations, and ceftriaxone.
  • Identifies amikacin as a newly associated antibiotic with TdP/QTP risk.
  • Highlights the importance of monitoring cardiac safety profiles of antibiotics.
Keywords:
QT prolongationTorsades de pointesadverse drug eventsantibioticsantimicrobial stewardship

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