title: Citalopram, QTc interval prolongation, and torsade de pointes. How should we apply the recent FDA ruling?
abstract: 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.
authors: Department of Psychiatry, Virginia Commonwealth University, Richmond, 23238-5414, USA. vvieweg@verizon.net
authors: W Victor R
authors: WV
authors: Vieweg
authors: Mehrul
authors: M
authors: Hasnain
authors: Robert H
authors: RH
authors: Howland
authors: John M
authors: JM
authors: Hettema
authors: Christopher
authors: C
authors: Kogut
authors: Mark A
authors: MA
authors: Wood
authors: Ananda K
authors: AK
authors: Pandurangi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018687:Antidepressive Agents, Second-Generation / Q000008:administration & dosage / Q000009:adverse effects*; D015283:Citalopram / Q000008:administration & dosage / Q000009:adverse effects*; D016757:Death, Sudden, Cardiac / Q000209:etiology; D004335:Drug and Narcotic Control; D005260:Female; D006352:Heart Ventricles / Q000187:drug effects; D006801:Humans; D008133:Long QT Syndrome / Q000139:chemically induced*; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D016171:Torsades de Pointes / Q000139:chemically induced*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D018687:Antidepressive Agents, Second-Generation; D015283:Citalopram; D017367:Selective Serotonin Reuptake Inhibitors