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.
['Barthez|Simon|S|', 'Revet|Alexis|A|https://orcid.org/0000-0002-8051-1657', 'Chouchana|Laurent|L|', 'Jonville-Bera|Annie-Pierre|AP|', 'Pizzoglio|Véronique|V|', 'Raynaud|Jean-Philippe|JP|', 'Chebane|Leila|L|', 'Lapeyre-Mestre|Maryse|M|', 'Montastruc|François|F|']
D000293:Adolescent D016907:Adverse Drug Reaction Reporting Systems D000928:Antidepressive Agents D002648:Child D002675:Child, Preschool D064420:Drug-Related Side Effects and Adverse Reactions D005260:Female D006801:Humans D007223:Infant D007231:Infant, Newborn D008297:Male D060735:Pharmacovigilance
Adverse drug reaction Children and adolescents Antidepressants Pharmacovigilance