Netherlands Pharmacovigilance Centre, 's-Hertogenbosch, The Netherlands
Department of Paediatrics, Medical Center Leeuwarden, Leeuwarden, The Netherlands.
Arch Dis Child. 2020 Aug;105(8):749-755. doi: 10.1136/archdischild-2019-317933. Epub 2020 Feb 14.
Due to lack of information on drug use in children, many drugs are used off-label in paediatrics. Increased knowledge of adverse drug reactions (ADRs) would enable a better risk-benefit analysis. Our aim was to characterise drugs causing psychiatric ADRs in children by conducting a descriptive study based on pharmacovigilance reports.
Reports submitted to the Netherlands Pharmacovigilance Centre Lareb from 2003 to 2016 were used to investigate drugs causing psychiatric ADRs in the Dutch paediatric population. These data were corrected for drug utilisation in order to correct the number of reports for the number of users of a drug.
ORs were calculated as a measure of disproportionality for drug-ADR associations for three different age groups. Significant drug-ADR associations were checked if it was labelled in the product information.
Lareb received 918 reports of psychiatric ADRs, which constitute 15% of the reports of ADRs in children. Drugs used for the treatment of ADHD (methylphenidate and atomoxetine) and drugs used for the treatment of asthma (montelukast and fluticasone) were the most frequently reported. However, psychiatric ADRs were also reported for less often prescribed medications such as oxybutynin and isotretinoin.
Real-world data on psychiatric ADRs in the Dutch paediatric population show a consistent pattern with what is known from drug labels and the literature. Reports of psychiatric ADRs should be taken seriously because of the impact on medication adherence and the well-being of the child and its family.
由于儿童用药信息匮乏，许多药物在儿科领域被超适应证使用。增加对药物不良反应（ADR）的了解将有助于更好地进行风险-效益分析。我们旨在通过开展基于药物警戒报告的描述性研究，确定导致儿童精神科 ADR 的药物。
利用 2003 年至 2016 年向荷兰药物警戒中心 Lareb 报告的病例，调查导致荷兰儿科人群发生精神科 ADR 的药物。为了校正药物报告数量，使药物报告数量与药物使用者数量相对应，对这些数据进行了校正。
计算比值比（OR）作为药物-ADR 关联性的比例失调度量，针对三个不同年龄组进行计算。对在产品信息中标记的显著药物-ADR 关联性进行检查。
Lareb 共收到 918 例精神科 ADR 报告，占儿童 ADR 报告的 15%。用于治疗 ADHD（哌甲酯和托莫西汀）和哮喘（孟鲁司特和氟替卡松）的药物是最常报告的药物。然而，奥昔布宁和异维 A 酸等使用频率较低的药物也报告了精神科 ADR。
荷兰儿科人群的真实世界精神科 ADR 数据与药物标签和文献中的已知情况一致。由于其对药物依从性和儿童及其家庭福祉的影响，应认真对待精神科 ADR 报告。
