Quetiapine is a low-affinity dopamine D2 receptor antagonist, approved for the treatment of bipolar disorder and schizophrenia in children and adolescents by the Food and Drug Administration, but not by European Medicine Agency. Although knowledge of adverse drug reactions in children and adolescents is scarce, quetiapine is increasingly being used for youth in Denmark. The aim of this case study is to discuss adverse drug events (ADEs) spontaneously reported to the Danish Medicines Agency on quetiapine used in the pediatric population in relation to adversive drug reactions (ADRs) reported in the European Summary of Product Characteristics (SPCs). The ADE report database at Danish Medicines Agency was searched for all quetiapine ADRs involving individuals (<18 years) in the period 1997-2015. Fifteen ADE case reports were retrieved, scrutinized, and categorized. The average age was 14.8 years (range 10-17 years) and six patients were boys. The main reported ADEs were (i) endocrine, for example, hyperprolactinemia and hyperthyroidism, (ii) cardiac, for example, tachycardia and QT prolongation, (iii) neurological, for example, seizures and cerebral hemorrhage, and (iv) psychiatric, for example, hallucinations. As some of the reported ADEs are life threatening and not listed as ADRs in the SPCs, off-label use of quetiapine in children and adolescents gives rise to safety concerns.

中文翻译：

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喹硫平治疗的儿童和青少年的不良事件：丹麦药品管理局数据库中药物不良反应报告的分析。

Quetiapine是一种低亲和力的多巴胺D2受体拮抗剂，已获得美国食品药品监督管理局（FDA）批准用于治疗儿童和青少年的双相情感障碍和精神分裂症，但未获得欧洲药品管理局（European Medicine Agency）的批准。尽管对儿童和青少年药物不良反应的了解很少，但喹硫平在丹麦的年轻人中越来越多地被使用。本案例研究的目的是讨论自发地向丹麦药品管理局报告的儿科人群中使用的喹硫平与药物不良反应（ADR）有关的不良药物事件（ADE）。在丹麦药品管理局的ADE报告数据库中，搜索了1997-2015年间涉及个人（<18岁）的所有喹硫平ADR。检索，审查了15份ADE案例报告，并进行分类。平均年龄为14.8岁（范围为10-17岁），其中6例为男孩。报告的主要ADE是（i）内分泌，例如高催乳素血症和甲状腺功能亢进；（ii）心脏，例如心动过速和QT延长；（iii）神经系统的，例如癫痫发作和脑出血；以及（iv）精神科，例如例如幻觉。由于一些已报道的ADEs危及生命，并且未在SPC中列为ADR，因此在儿童和青少年中超标使用喹硫平引起了安全隐患。癫痫发作和脑出血，以及（iv）精神病，例如幻觉。由于一些已报道的ADEs危及生命，并且未在SPC中列为ADR，因此在儿童和青少年中超标使用喹硫平引起了安全隐患。癫痫发作和脑出血，以及（iv）精神病，例如幻觉。由于一些已报道的ADEs危及生命，并且未在SPC中列为ADR，因此在儿童和青少年中超标使用喹硫平引起了安全隐患。