Citalopram, QTc Interval Prolongation, and Torsade de Pointes. How Should We Apply the Recent FDA Ruling?

Vieweg, W. Victor R.; Hasnain, Mehrul; Howland, Robert H; Hettema, John M.; Kogut, Christopher; Wood, Mark A.; Pandurangi, Anand K.

doi:10.1016/j.amjmed.2011.12.002

Cited by 261 publications

(76 citation statements)

References 31 publications

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“…We continue to believe that drugs such as azithromycin linked to QTc interval prolongation and/ or torsade de pointes are only one of the likely factors explaining these electrocardiographic changes [Vieweg et al 2012Hasnain et al 2013]. We continue to urge regulatory agencies and pharmaceutical manufacturers to make available to the public case report material (narrative medicine) [Vieweg et al 2012Hasnain et al 2013].…”

Section: Regulatory Agency Concernsmentioning

confidence: 99%

“…We continue to urge regulatory agencies and pharmaceutical manufacturers to make available to the public case report material (narrative medicine) [Vieweg et al 2012Hasnain et al 2013]. Specifically, elderly women with heart disease are at greatest risk for azithromycin-related QTc interval prolongation and torsade de pointes and we propose identifying this triad as major risk factors.…”

Section: Regulatory Agency Concernsmentioning

confidence: 99%

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Azithromycin, cardiovascular risks, QTc interval prolongation, torsade de pointes, and regulatory issues: A narrative review based on the study of case reports

Hancox

Hasnain

Vieweg

et al. 2013

Therapeutic Advances in Infection

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Over the past year, three articles have appeared in the New England Journal of Medicine describing conflicting findings about azithromycin and cardiac safety, particular azithromycin-induced QTc interval prolongation and torsade de pointes. The FDA wants healthcare providers to consider azithromycin-induced fatal cardiac arrhythmias for patients already at risk for cardiac death and other potentially arrhythmogenic cardiovascular conditions. In a systematic review of case reports we sought to determine factors that link to azithromycininduced/associated QTc interval prolongation and torsade de pointes. We found 12 cases: seven female and five male. Of the nine adults with reported azithromycin doses, concurrent QTc interval measurement, and without congenital long QT syndrome, we found no significant relationship between dose and QTc interval duration. Additional risk factors were female sex, older age, heart disease, QTc interval prolonging drugs and metabolic inhibitors, hypokalemia, and bradycardia. All 12 subjects had at least two additional risk factors. Elderly women with heart disease appear to be at particularly risk for drug-related QTc interval prolongation and torsade de pointes.

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Section: Regulatory Agency Concernsmentioning

confidence: 99%

Section: Regulatory Agency Concernsmentioning

confidence: 99%

Azithromycin, cardiovascular risks, QTc interval prolongation, torsade de pointes, and regulatory issues: A narrative review based on the study of case reports

Hancox

Hasnain

Vieweg

et al. 2013

Therapeutic Advances in Infection

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“…Citalopram has been reputed to have a good safety profile within the clinical concentration range making it an attractive alternative to tricyclic antidepressants [2,9]. However, there is some evidence of QT prolongation and arrhythmia with citalopram (for reviews see [7,8,10]). Reviews of data from United States and Swedish adverse effect registries note ~20 cases of TdP associated with citalopram [8,11], with a number of additional case reports in the literature (for a recent review see: [12]).…”

Section: Citalopram Escitalopram and Qt Prolongationmentioning

confidence: 99%

Towards limiting QT interval prolongation and arrhythmia risk in citalopram use

2014

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“…Rather than attempting to develop a database that can be analyzed using parametric statistics, we employed the principles of narrative medicine in a case report format as we have in our other papers assessing psychotropic drug-induced QTc interval prolongation and TdP [Vieweg, 2003;Vieweg et al 2004;Vieweg et al 2005;Vieweg et al 2009;Vieweg et al 2012]. Data from our review of case reports in the literature and analyses of those data form the body of our paper.…”

Section: Case Report Formatmentioning

confidence: 99%

Methadone, QTc interval prolongation and torsade de pointes: Case reports offer the best understanding of this problem

Vieweg

Hasnain

Howland

et al. 2013

Therapeutic Advances in Psychopharmacology

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Abstract:We reviewed the literature and found 31 adult cases and 1 newborn case of methadone-associated QTc interval prolongation and/or torsade de pointes (TdP). Parametric statistics may not be useful in studying this issue because methadone-associated TdP is a very rare event and, hence, "an extreme outlier" consistent with scalable randomness. We may have to rely upon narrative medicine in the form of case reports with all its limitations and hazards to provide our best understanding. We report risk factors for methadone-associated QTc interval prolongation and TdP based on review of published case reports. We believe both drug manufacturers and the FDA would better serve our patients and inform clinicians if they more readily reported drug-induced outliers such as methadone-associated TdP using a case report format.

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Citalopram, QTc Interval Prolongation, and Torsade de Pointes. How Should We Apply the Recent FDA Ruling?

Cited by 261 publications

References 31 publications

Azithromycin, cardiovascular risks, QTc interval prolongation, torsade de pointes, and regulatory issues: A narrative review based on the study of case reports

Azithromycin, cardiovascular risks, QTc interval prolongation, torsade de pointes, and regulatory issues: A narrative review based on the study of case reports

Towards limiting QT interval prolongation and arrhythmia risk in citalopram use

Methadone, QTc interval prolongation and torsade de pointes: Case reports offer the best understanding of this problem

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