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

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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)

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

Suggested Citation

  • Ana Aldea Perona & Mar García-Sáiz & Emilio Sanz Álvarez, 2016. "Psychiatric Disorders and Montelukast in Children: A Disproportionality Analysis of the VigiBase®," Drug Safety, Springer, vol. 39(1), pages 69-78, January.
    • Handle: RePEc:spr:drugsa:v:39:y:2016:i:1:d:10.1007_s40264-015-0360-2
    DOI: 10.1007/s40264-015-0360-2
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    Cited by:

    1. Sharon W. Y. Law & Angel Y. S. Wong & Shweta Anand & Ian C. K. Wong & Esther W. Chan, 2018. "Neuropsychiatric Events Associated with Leukotriene-Modifying Agents: A Systematic Review," Drug Safety, Springer, vol. 41(3), pages 253-265, March.

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