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.

译文

最近,西酞普兰的制造商和美国食品药品监督管理局都警告医疗保健提供者和患者,当使用剂量> 40 mg/天的西酞普兰时,有关药物诱导的QTc间隔延长和尖端扭转型的新信息。在现实世界的临床实践中,这一警告没有被置于益处或风险的背景下,使临床医生在剥夺患者大剂量西酞普兰或医疗事故诉讼之间做出了站不住脚的选择。我们回顾了文献,发现服用西酞普兰高达60 mg/天的患者中没有西酞普兰诱发的心源性猝死病例,并且没有QTc间隔延长和尖端扭转型的危险因素。由于在没有确定的QTc间隔延长和尖端扭转型风险因素的情况下,精神药物引起的心脏猝死是一个异常值,因此我们认为当前的第3阶段和第4阶段研究无法提供足够的信息来限制当前西酞普兰的处方实践 (20 mg至60 mg/天)。我们敦促药品制造商和监管机构定期发布精神药物引起的QTc间期延长,尖端扭转型和心脏性猝死的完整病例报告,以便临床医生和研究人员更好地了解西酞普兰等药物的临床意义。

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