Adverse drug reactions in infants, children and adolescents exposed to antidepressants: a French pharmacovigilance study
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PHARMACOEPIDEMIOLOGY AND PRESCRIPTION
Adverse drug reactions in infants, children and adolescents exposed to antidepressants: a French pharmacovigilance study Simon Barthez 1,2 & Alexis Revet 1,2 & Laurent Chouchana 3 & Annie-Pierre Jonville-Bera 4 & Véronique Pizzoglio 5 & Jean-Philippe Raynaud 1,2 & Leila Chebane 6 & Maryse Lapeyre-Mestre 1,7 & François Montastruc 1,6,7 Received: 12 March 2020 / Accepted: 19 June 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract Purpose Despite their frequent use in children and adolescents, the evidence for efficacy and safety of antidepressants (ATDs) in this population is scarce and off-label prescribing common. The aim of this study was to describe reported adverse drug reactions (ADRs) associated to ATDs over a 30-year period using the French Pharmacovigilance Database (FPVD). Methods We performed an analysis of ADRs registered in the FPVD from 1985 to 2016, occurred in children and adolescents receiving an ATD. Descriptive statistics were used to obtain an overview of ADRs types and characteristics, and data were stratified by age. Results Among the 45,070 pediatric cases reports registered into the FPVD, we identified 1366 reports (3.0%) in which ATDs were “suspected” as the cause of 2922 ADRs. ADRs were more frequently reported in female (n = 743; 55.5%) and adolescents (n = 627; 49.3%). Neuropsychiatric ADRs were the most reported, mainly sleepiness, agitation, and suicidal thinking and behavior, followed by gastrointestinal and hepatobiliary disorders, mainly vomiting, abdominal pain, hepatitis, nausea, and three unexpected ADRs of pancreatitis. There was an increase of annual reporting between 1986 and 2003, followed by a plateau state then a decrease from 2003 to 2012, and a rapid escalation until 2016, while an increase in the number of reporting of suicidal thinking and behavior was observed after 2003, highlighting a possible impact of black box warnings on reporting practices and ATD use. Conclusion This pediatric pharmacovigilance study underscored the high prevalence of neuropsychiatric and gastrointestinal ADRs, including three unexpected cases of pancreatitis. Keywords Antidepressants . Adverse drug reaction . Children and adolescents . Pharmacovigilance
Simon Barthez and Alexis Revet contributed equally to this work. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00228-020-02944-7) contains supplementary material, which is available to authorized users. * Alexis Revet [email protected] 1
UMR 1027, Inserm, Université Toulouse III, Toulouse, France
2
Service Universitaire de Psychiatrie de l’Enfant et de l’Adolescent, CHU de Toulouse, Hôpital Purpan, Place du Dr Baylac, TSA 40031, 31059 Toulouse Cedex 9, France
3
Centre Régional de Pharmacovigilance, Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Paris, France
4
Centre Régional de Pharmacovigilance Centre-Val de Loire, Service de Pharmacosurveillance, CHRU de Tours, Tours, France
5
Service Hospitalo-Universitaire
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