Citalopram, QTc interval prolongation, and torsade de pointes. How should we apply the recent FDA ruling?

Am J Med. 2012 Sep;125(9):859-68. doi: 10.1016/j.amjmed.2011.12.002. Epub 2012 Jun 27.


Recently, both the manufacturer of citalopram and the US Food and Drug Administration have warned health care providers and patients about new information implicating drug-induced QTc interval prolongation and torsade de pointes when using citalopram in doses >40 mg/day. This warning is not placed in the context of either benefits or risks in real-world clinical practice, leaving clinicians with an untenable choice between depriving patients of high-dose citalopram or malpractice litigation. We reviewed the literature and found no cases of citalopram-induced sudden cardiac death among patients taking up to 60 mg/day of citalopram and free of risk factors for QTc interval prolongation and torsade de pointes. Because psychotropic drug-induced sudden cardiac death is an outlier in the absence of identified risk factors for QTc interval prolongation and torsade de pointes, we do not believe current Phase 3 and Phase 4 studies provide sufficient information to limit current prescribing practices for citalopram (20 mg to 60 mg/day). We urge drug manufacturers and regulatory agencies to periodically publish full case reports of psychotropic drug-induced QTc interval prolongation, torsade de pointes, and sudden cardiac death so that clinicians and investigators may better understand the clinical implications of prescribing such drugs as citalopram.

Publication types

  • Case Reports
  • Review

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antidepressive Agents, Second-Generation / administration & dosage
  • Antidepressive Agents, Second-Generation / adverse effects*
  • Citalopram / administration & dosage
  • Citalopram / adverse effects*
  • Death, Sudden, Cardiac / etiology
  • Drug and Narcotic Control*
  • Female
  • Heart Ventricles / drug effects
  • Humans
  • Long QT Syndrome / chemically induced*
  • Male
  • Middle Aged
  • Risk Factors
  • Selective Serotonin Reuptake Inhibitors / administration & dosage
  • Selective Serotonin Reuptake Inhibitors / adverse effects*
  • Torsades de Pointes / chemically induced*
  • United States
  • United States Food and Drug Administration


  • Antidepressive Agents, Second-Generation
  • Serotonin Uptake Inhibitors
  • Citalopram