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Adverse Drug Reactions in Infants, Children and Adolescents Exposed to Antidepressants: A French Pharmacovigilance Study
- Source :
- European journal of clinical pharmacology, European journal of clinical pharmacology, 2020, ⟨10.1007/s00228-020-02944-7⟩
- Publication Year :
- 2020
- Publisher :
- HAL CCSD, 2020.
-
Abstract
- International audience; 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.
- Subjects :
- Male
Abdominal pain
Pediatrics
medicine.medical_specialty
Children and adolescents
Adolescent
Drug-Related Side Effects and Adverse Reactions
Nausea
[SDV]Life Sciences [q-bio]
Population
Adverse drug reaction
030226 pharmacology & pharmacy
03 medical and health sciences
Pharmacovigilance
0302 clinical medicine
Medicine
Adverse Drug Reaction Reporting Systems
Humans
Pharmacology (medical)
030212 general & internal medicine
education
Child
Pharmacology
Hepatitis
education.field_of_study
business.industry
Infant, Newborn
Infant
General Medicine
Antidepressants
medicine.disease
Antidepressive Agents
3. Good health
Child, Preschool
Vomiting
Pancreatitis
Female
medicine.symptom
business
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- European journal of clinical pharmacology, European journal of clinical pharmacology, 2020, ⟨10.1007/s00228-020-02944-7⟩
- Accession number :
- edsair.doi.dedup.....f541d514b509c780098995b584280b86