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

Ana Aldea Perona, Mar García-Sáiz and Emilio Sanz Álvarez ()
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Ana Aldea Perona: Hospital Universitario de Canarias
Mar García-Sáiz: Hospital Universitario de Canarias
Emilio Sanz Álvarez: University of La Laguna

Drug Safety, 2016, vol. 39, issue 1, No 7, 69-78

Abstract: Abstract Introduction 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. Aim Our objective was to analyse spontaneous reports of psychiatric events in children and adolescents worldwide treated with montelukast. Methods 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. Results A total of 14,670 ICSRs for montelukast were recorded, of which 2630 corresponded to psychiatric disorders in people aged

Date: 2016
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DOI: 10.1007/s40264-015-0360-2

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