Adverse drug reactions in infants, children and adolescents exposed to antidepressants: a French pharmacovigilance study.
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.
|ジャーナル名||European journal of clinical pharmacology|
|投稿者||Barthez, Simon; Revet, Alexis; Chouchana, Laurent; Jonville-Bera, Annie-Pierre; Pizzoglio, Veronique; Raynaud, Jean-Philippe; Chebane, Leila; Lapeyre-Mestre, Maryse; Montastruc, Francois|
|組織名||UMR 1027, Inserm, Universite Toulouse III, Toulouse, France.;Service Universitaire de Psychiatrie de l'Enfant et de l'Adolescent, CHU de;Toulouse, Hopital Purpan, Place du Dr Baylac, TSA 40031, 31059, Toulouse Cedex 9,;France.;email@example.com.;France. firstname.lastname@example.org.;Centre Regional de Pharmacovigilance, Assistance Publique-Hopitaux de Paris,;Hopital Cochin, Paris, France.;Centre Regional de Pharmacovigilance Centre-Val de Loire, Service de;Pharmacosurveillance, CHRU de Tours, Tours, France.;Service Hospitalo-Universitaire de Pharmacotoxicologie, Centre de;Pharmacovigilance, Hospices Civils de Lyon, CHU-Lyon, Lyon, France.;Service de Pharmacologie Medicale et Clinique, Centre de Pharmacovigilance, de;Pharmacoepidemiologie et d'Informations sur le Medicament, Faculte de Medecine,;CHU de Toulouse, Toulouse, France.;CIC 1436, CHU de Toulouse, Toulouse, France.|