Open AccessAdverse drug reactions of montelukast in children and adults
Author(s) -
Haarman Meindina G.,
Hunsel Florence,
Vries Tjalling W.
Publication year - 2017
Publication title -
pharmacology research and perspectives
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.975
H-Index - 27
ISSN - 2052-1707
DOI - 10.1002/prp2.341
Subject(s) - montelukast , medicine , pharmacovigilance , leukotriene receptor , asthma , adverse effect , odds ratio , pediatrics , meddra , depression (economics) , database , computer science , economics , macroeconomics
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.