Aagaard Lise, Hansen Ebba H
Department of Pharmacology and Pharmacotherapy, Section for Social Pharmacy, Faculty of Pharmaceutical Sciences, University of Copenhagen, Denmark.
BMC Res Notes. 2010 Jun 23;3:176. doi: 10.1186/1756-0500-3-176.
The prescribing of psychotropic medicines for the paediatric population is rapidly increasing. In attempts to curb the use of psychotropic medicine in the paediatric population, regulatory authorities have issued various warnings about risks associated with use of these products in childhood. Little evidence has been reported about the adverse drug reactions (ADRs) of these medicines in practice. As spontaneous reports are the main source for information about previously unknown ADRs, we analysed data submitted to a national ADR database. The objective was to characterise ADRs reported for psychotropic medicines in the Danish paediatric population over a decade.
All spontaneous ADR reports from 1998 to 2007 for children from birth to 17 years of age were included. The unit of analysis was one ADR. We analysed the distribution of ADRs per year, seriousness, age and gender of the child, suspected medicine and type of reported ADR. A total of 429 ADRs were reported for psychotropic medicines and 56% of these were classified as serious. Almost 20% of psychotropic ADRs were reported for children from birth up to 2 years of age and one half of ADRs were reported in adolescents, especially for antidepressants and psychostimulants. Approximately 60% of ADRs were reported for boys. Forty percent of all ADRs were from the category 'nervous and psychiatric disorders'. All but one ADR reported for children below two years were serious and two of these were fatal. A number of serious ADRs reported in children from birth up to 2 years of age were presumably caused by mothers' use of psychotropic medicines during pregnancy.
The high number of serious ADRs reported for psychotropic medicines in the paediatric population should be a concern for health care professionals and physicians. Considering the higher number of birth defects being reported greater care has to be given while prescribing these drugs for pregnant women.
用于儿科人群的精神药物处方量正在迅速增加。为了遏制儿科人群中精神药物的使用，监管机构已就这些产品在儿童期使用的相关风险发布了各种警告。在实际应用中，关于这些药物的药物不良反应（ADR）的报道证据很少。由于自发报告是获取此前未知ADR信息的主要来源，我们分析了提交至一个国家ADR数据库的数据。目的是描述丹麦儿科人群在十年间报告的精神药物ADR特征。
纳入了1998年至2007年所有针对出生至17岁儿童的自发ADR报告。分析单位为一例ADR。我们分析了每年ADR的分布情况、严重程度、儿童的年龄和性别、可疑药物以及报告的ADR类型。共报告了429例精神药物ADR，其中56%被归类为严重ADR。近20%的精神药物ADR报告来自出生至2岁的儿童，一半的ADR报告来自青少年，尤其是抗抑郁药和精神兴奋剂。约60%的ADR报告来自男孩。所有ADR中有40%属于“神经和精神障碍”类别。报告的2岁以下儿童的ADR中，除一例之外均为严重ADR，其中两例是致命的。出生至2岁儿童报告的一些严重ADR可能是由于母亲在孕期使用精神药物所致。
儿科人群中报告的精神药物严重ADR数量众多，这应引起医疗保健专业人员和医生的关注。鉴于报告的出生缺陷数量增多，在为孕妇开具这些药物时必须格外谨慎。
