Psychiatric Disorders and Montelukast in Children: A Disproportionality Analysis of the VigiBase®

In 2008, the US FDA issued an alert about an increased risk of psychiatric events associated with montelukast. Recent national pharmacovigilance analyses in Sweden, France and Spain detected a potential increase in reporting risk of the association. Our objective was to analyse spontaneous reports of psychiatric events in children and adolescents worldwide treated with montelukast. We conducted a retrospective analysis of Individual Case Safety Reports (ICSRs) recorded up to 1 January 2015 in the World Health Organization (WHO) database (VigiBase®), in which montelukast was associated with ‘psychiatric disorders’. We used the Bayesian Confidence Propagation Neural Network (BCPNN) approach for signal generation. A total of 14,670 ICSRs for montelukast were recorded, of which 2630 corresponded to psychiatric disorders in people aged