| アブストラクト | 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((R)) until 2016. Depression was reported most frequently in the whole population to the global database VigiBase((R)) (reporting odds ratio (ROR) 6.93; 95% CI: 6.5-7.4). In the VigiBase((R)) , 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((R)) . 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. |
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| 投稿日 | 2017/10/4 |
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| 投稿者 | Haarman, Meindina G; van Hunsel, Florence; de Vries, Tjalling W |
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| ジャーナル名 | Pharmacology research & perspectives |
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| 組織名 | 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.;Department of Pediatrics, Medical Center Leeuwarden, Leeuwarden, The Netherlands. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/28971612/ |
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