Department of Pediatric Cardiology, Center for Congenital Heart Diseases, Beatrix Children's Hospital, University Medical Center Groningen, The Netherlands.
Netherlands Pharmacovigilance Center Lareb, Den Bosch, The Netherlands.
Pharmacol Res Perspect. 2017 Oct;5(5). doi: 10.1002/prp2.341.
Montelukast, a selective leukotriene receptor antagonist, is recommended in guidelines for the treatment of asthma in both children and adults. However, its effectiveness is debated, and recent studies have reported several adverse events such as neuropsychiatric disorders and allergic granulomatous angiitis. This study aims to obtain more insight into the safety profile of montelukast and to provide prescribing physicians with an overview of relevant adverse drug reactions in both children and adults. We retrospectively studied all adverse drug reactions on montelukast in children and adults reported to the Netherlands Pharmacovigilance Center Lareb and the WHO Global database, VigiBase until 2016. Depression was reported most frequently in the whole population to the global database VigiBase (reporting odds ratio (ROR) 6.93; 95% CI: 6.5-7.4). In the VigiBase , aggression was reported the most in children (ROR, 29.77; 95% CI: 27.5-32.2). Headaches were reported the most frequently to the Dutch database (ROR, 2.26; 95% CI: 1.61-3.19). Furthermore, nightmares are often reported for both children and adults to the Dutch and the global database. Eight patients with allergic granulomatous angiitis were reported to the Dutch database and 563 patients in the VigiBase . These data demonstrate that montelukast is associated with neuropsychiatric adverse drug reactions such as depression and aggression. Especially in children nightmares are reported frequently. Allergic granulomatous angiitis is also reported, a causal relationship has not been established.
孟鲁司特，一种选择性白三烯受体拮抗剂，被推荐用于儿童和成人哮喘的治疗指南。然而，其疗效存在争议，最近的研究报告了几种不良事件，如神经精神障碍和过敏性肉芽肿性血管炎。本研究旨在更深入地了解孟鲁司特的安全性概况，并为儿科和成人的处方医生提供相关药物不良反应的概述。我们回顾性研究了荷兰药物警戒中心 Lareb 和世界卫生组织全球数据库 VigiBase 报告的儿童和成人使用孟鲁司特的所有药物不良反应，直到 2016 年。全球数据库 VigiBase 报告的抑郁在全人群中最为常见（报告比值比（ROR）6.93；95%可信区间：6.5-7.4）。在 VigiBase 中，攻击性在儿童中报告最多（ROR，29.77；95%可信区间：27.5-32.2）。头痛在荷兰数据库中报告最多（ROR，2.26；95%可信区间：1.61-3.19）。此外，噩梦在荷兰和全球数据库中经常被报告给儿童和成人。荷兰数据库报告了 8 例过敏性肉芽肿性血管炎患者，全球数据库 VigiBase 报告了 563 例。这些数据表明，孟鲁司特与神经精神不良反应相关，如抑郁和攻击。特别是在儿童中，经常报告噩梦。也报告了过敏性肉芽肿性血管炎，但尚未建立因果关系。
