Department of Psychiatry, Virginia Commonwealth University, Richmond, 23238-5414, USA.
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.
最近，西酞普兰的制造商和美国食品药品监督管理局都向医疗保健提供者和患者发出警告，称在使用西酞普兰剂量超过 40 毫克/天时，新的信息表明其可能导致 QTc 间期延长和尖端扭转型室性心动过速。该警告并未放在实际临床实践中的获益或风险的背景下，这使得临床医生在剥夺患者使用高剂量西酞普兰和面临医疗事故诉讼之间做出无法承受的选择。我们查阅了文献，没有发现服用高达 60 毫克/天的西酞普兰且没有 QTc 间期延长和尖端扭转型室性心动过速风险因素的患者出现西酞普兰导致的心脏性猝死的病例。因为在没有明确的 QTc 间期延长和尖端扭转型室性心动过速风险因素的情况下，精神药物导致的心脏性猝死是一个异常事件，因此我们认为目前的 3 期和 4 期研究并没有提供足够的信息来限制西酞普兰（20 毫克至 60 毫克/天）的当前处方实践。我们敦促药品制造商和监管机构定期公布精神药物导致的 QTc 间期延长、尖端扭转型室性心动过速和心脏性猝死的完整病例报告，以便临床医生和研究人员可以更好地理解开具此类药物（如西酞普兰）的临床意义。
