Cargando…

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

Introduction: Macrolides, linezolid, imipenem-cilastatin, fluoroquinolones, penicillin combinations, and ceftriaxone are known to be associated with Torsades de pointes/QT prolongation (TdP/QTP). Other antibiotics may also lead to TdP/QTP, but no study has systemically compared TdP/QTP associations...

Descripción completa

Detalles Bibliográficos
Autores principales: Teng, Chengwen, Walter, Elizabeth A., Gaspar, Daryl Kevin S., Obodozie-Ofoegbu, Obiageri O., Frei, Christopher R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Ivyspring International Publisher 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6643131/
https://www.ncbi.nlm.nih.gov/pubmed/31341415
http://dx.doi.org/10.7150/ijms.34141
_version_ 1783437078350004224
author Teng, Chengwen
Walter, Elizabeth A.
Gaspar, Daryl Kevin S.
Obodozie-Ofoegbu, Obiageri O.
Frei, Christopher R.
author_facet Teng, Chengwen
Walter, Elizabeth A.
Gaspar, Daryl Kevin S.
Obodozie-Ofoegbu, Obiageri O.
Frei, Christopher R.
author_sort Teng, Chengwen
collection PubMed
description Introduction: Macrolides, linezolid, imipenem-cilastatin, fluoroquinolones, penicillin combinations, and ceftriaxone are known to be associated with Torsades de pointes/QT prolongation (TdP/QTP). Other antibiotics may also lead to TdP/QTP, but no study has systemically compared TdP/QTP associations for many available antibiotics. Objectives: The objective of this study was to evaluate the association between TdP/QTP and many available antibiotics using the FDA Adverse Event Report System (FAERS). Methods: FAERS reports from January 1, 2015 to December 31, 2017 were analyzed. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify TdP/QTP cases. We calculated the Reporting Odds Ratios (RORs) and corresponding 95% confidence intervals (95%CI) for the association between antibiotics and TdP/QTP. An association was considered to be statistically significant when the lower limit of the 95%CI was greater than 1.0. Results: A total of 2,042,801 reports (including 3,960 TdP/QTP reports) were considered, after inclusion criteria were applied. Macrolides had the greatest proportion of TdP/QTP reports. Of the 4,092 reports associated with macrolides, 108 reports (2.6%) were associated with TdP/QTP. Significant TdP/QTP RORs (95%CI) for the antibiotics were (in descending order): 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). Conclusion: This study confirms prior evidence for TdP/QTP associations with macrolides, linezolid, imipenem-cilastatin, fluoroquinolones, penicillin combinations, and ceftriaxone. This study also identifies a new association between amikacin and TdP/QTP.
format Online
Article
Text
id pubmed-6643131
institution National Center for Biotechnology Information
language English
publishDate 2019
publisher Ivyspring International Publisher
record_format MEDLINE/PubMed
spelling pubmed-66431312019-07-24 Torsades de pointes and QT prolongation Associations with Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System Teng, Chengwen Walter, Elizabeth A. Gaspar, Daryl Kevin S. Obodozie-Ofoegbu, Obiageri O. Frei, Christopher R. Int J Med Sci Research Paper Introduction: Macrolides, linezolid, imipenem-cilastatin, fluoroquinolones, penicillin combinations, and ceftriaxone are known to be associated with Torsades de pointes/QT prolongation (TdP/QTP). Other antibiotics may also lead to TdP/QTP, but no study has systemically compared TdP/QTP associations for many available antibiotics. Objectives: The objective of this study was to evaluate the association between TdP/QTP and many available antibiotics using the FDA Adverse Event Report System (FAERS). Methods: FAERS reports from January 1, 2015 to December 31, 2017 were analyzed. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify TdP/QTP cases. We calculated the Reporting Odds Ratios (RORs) and corresponding 95% confidence intervals (95%CI) for the association between antibiotics and TdP/QTP. An association was considered to be statistically significant when the lower limit of the 95%CI was greater than 1.0. Results: A total of 2,042,801 reports (including 3,960 TdP/QTP reports) were considered, after inclusion criteria were applied. Macrolides had the greatest proportion of TdP/QTP reports. Of the 4,092 reports associated with macrolides, 108 reports (2.6%) were associated with TdP/QTP. Significant TdP/QTP RORs (95%CI) for the antibiotics were (in descending order): 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). Conclusion: This study confirms prior evidence for TdP/QTP associations with macrolides, linezolid, imipenem-cilastatin, fluoroquinolones, penicillin combinations, and ceftriaxone. This study also identifies a new association between amikacin and TdP/QTP. Ivyspring International Publisher 2019-06-10 /pmc/articles/PMC6643131/ /pubmed/31341415 http://dx.doi.org/10.7150/ijms.34141 Text en © Ivyspring International Publisher This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY-NC) license (https://creativecommons.org/licenses/by-nc/4.0/). See http://ivyspring.com/terms for full terms and conditions.
spellingShingle Research Paper
Teng, Chengwen
Walter, Elizabeth A.
Gaspar, Daryl Kevin S.
Obodozie-Ofoegbu, Obiageri O.
Frei, Christopher R.
Torsades de pointes and QT prolongation Associations with Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System
title Torsades de pointes and QT prolongation Associations with Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System
title_full Torsades de pointes and QT prolongation Associations with Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System
title_fullStr Torsades de pointes and QT prolongation Associations with Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System
title_full_unstemmed Torsades de pointes and QT prolongation Associations with Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System
title_short Torsades de pointes and QT prolongation Associations with Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System
title_sort torsades de pointes and qt prolongation associations with antibiotics: a pharmacovigilance study of the fda adverse event reporting system
topic Research Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6643131/
https://www.ncbi.nlm.nih.gov/pubmed/31341415
http://dx.doi.org/10.7150/ijms.34141
work_keys_str_mv AT tengchengwen torsadesdepointesandqtprolongationassociationswithantibioticsapharmacovigilancestudyofthefdaadverseeventreportingsystem
AT walterelizabetha torsadesdepointesandqtprolongationassociationswithantibioticsapharmacovigilancestudyofthefdaadverseeventreportingsystem
AT gaspardarylkevins torsadesdepointesandqtprolongationassociationswithantibioticsapharmacovigilancestudyofthefdaadverseeventreportingsystem
AT obodozieofoegbuobiagerio torsadesdepointesandqtprolongationassociationswithantibioticsapharmacovigilancestudyofthefdaadverseeventreportingsystem
AT freichristopherr torsadesdepointesandqtprolongationassociationswithantibioticsapharmacovigilancestudyofthefdaadverseeventreportingsystem