Montelukast: neuropsychiatric adverse drug reactions in Tunisian asthmatic children

Introduction: Montelukast is a widely prescribed treatment in childhood asthma. But, in 2017, two large studies confirmed that it was associated with neuropsychiatric adverse drug reactions (ADR), about one-third of which concerned children. The aim was to analyze the frequency of psychiatric ADR that happened in children taking Montelukast for their asthma and to describe the characteristics of patients with these ADR. Methods: We collected by means of phone call all neuropsychiatric ADR in 56 children followed for asthma and receiving Montelukast. Results: The mean age was 7.03years (2-17 years). Asthma was moderate to severe in 36 % of cases. All children received Montelukast as an add-on therapy with inhaled steroids. As in literature, neuropsychiatric ADR were reported in 32% of cases. They happened 2.75 weeks (1-24 weeks) after treatment initiation, and in 21% of the cases, before 2 weeks. The majority of ADR were benign: irritability (25%), agitation (18%), aggressiveness (20%), anxiety (12%), nightmares (12%), insomnia (4%) and drop in school performance (3%). No suicidal attitude or ideas were reported. Treatment was stopped by parents in 2 cases (3%) because of extreme aggressiveness, with a good outcome. Asthma was non-controlled in these two cases. For the other children, treatment was not interrupted because side effects were transient. Age< 4 years and asthma severity were not associated with the occurrence with the psychiatric ADR. Conclusion: neuropsychiatric ADR in children taking Montelukast were frequent but not serious. The question of whether these ADR are exclusively related to Montelukast or may be influenced by the fact of living with a chronic disease is left open