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Adverse events in children and adolescents treated with quetiapine: an analysis of adverse drug reaction reports from the Danish Medicines Agency database.
Int Clin Psychopharmacol. 2017 03; 32(2):103-106.IC

Abstract

Quetiapine is a low-affinity dopamine D2 receptor antagonist, approved for the treatment of bipolar disorder and schizophrenia in children and adolescents by the Food and Drug Administration, but not by European Medicine Agency. Although knowledge of adverse drug reactions in children and adolescents is scarce, quetiapine is increasingly being used for youth in Denmark. The aim of this case study is to discuss adverse drug events (ADEs) spontaneously reported to the Danish Medicines Agency on quetiapine used in the pediatric population in relation to adversive drug reactions (ADRs) reported in the European Summary of Product Characteristics (SPCs). The ADE report database at Danish Medicines Agency was searched for all quetiapine ADRs involving individuals (<18 years) in the period 1997-2015. Fifteen ADE case reports were retrieved, scrutinized, and categorized. The average age was 14.8 years (range 10-17 years) and six patients were boys. The main reported ADEs were (i) endocrine, for example, hyperprolactinemia and hyperthyroidism, (ii) cardiac, for example, tachycardia and QT prolongation, (iii) neurological, for example, seizures and cerebral hemorrhage, and (iv) psychiatric, for example, hallucinations. As some of the reported ADEs are life threatening and not listed as ADRs in the SPCs, off-label use of quetiapine in children and adolescents gives rise to safety concerns.

Authors+Show Affiliations

aDepartment of Clinical Medicine, Aalborg University bDepartment of Psychiatry, Aalborg University Hospital, Aalborg cDanish Medicines Agency dCentre for Child and Adolescent Mental Health eMental Health Centre Copenhagen, Mental Health Services, Capital Region of Denmark fDepartment of Neuroscience and Pharmacology, University of Copenhagen, Copenhagen, Denmark.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27685179

Citation

Jakobsen, Klaus D., et al. "Adverse Events in Children and Adolescents Treated With Quetiapine: an Analysis of Adverse Drug Reaction Reports From the Danish Medicines Agency Database." International Clinical Psychopharmacology, vol. 32, no. 2, 2017, pp. 103-106.
Jakobsen KD, Wallach-Kildemoes H, Bruhn CH, et al. Adverse events in children and adolescents treated with quetiapine: an analysis of adverse drug reaction reports from the Danish Medicines Agency database. Int Clin Psychopharmacol. 2017;32(2):103-106.
Jakobsen, K. D., Wallach-Kildemoes, H., Bruhn, C. H., Hashemi, N., Pagsberg, A. K., Fink-Jensen, A., & Nielsen, J. (2017). Adverse events in children and adolescents treated with quetiapine: an analysis of adverse drug reaction reports from the Danish Medicines Agency database. International Clinical Psychopharmacology, 32(2), 103-106. https://doi.org/10.1097/YIC.0000000000000148
Jakobsen KD, et al. Adverse Events in Children and Adolescents Treated With Quetiapine: an Analysis of Adverse Drug Reaction Reports From the Danish Medicines Agency Database. Int Clin Psychopharmacol. 2017;32(2):103-106. PubMed PMID: 27685179.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Adverse events in children and adolescents treated with quetiapine: an analysis of adverse drug reaction reports from the Danish Medicines Agency database. AU - Jakobsen,Klaus D, AU - Wallach-Kildemoes,Helle, AU - Bruhn,Christina H, AU - Hashemi,Nasseh, AU - Pagsberg,Anne K, AU - Fink-Jensen,Anders, AU - Nielsen,Jimmi, PY - 2016/9/30/pubmed PY - 2017/11/29/medline PY - 2016/9/30/entrez SP - 103 EP - 106 JF - International clinical psychopharmacology JO - Int Clin Psychopharmacol VL - 32 IS - 2 N2 - Quetiapine is a low-affinity dopamine D2 receptor antagonist, approved for the treatment of bipolar disorder and schizophrenia in children and adolescents by the Food and Drug Administration, but not by European Medicine Agency. Although knowledge of adverse drug reactions in children and adolescents is scarce, quetiapine is increasingly being used for youth in Denmark. The aim of this case study is to discuss adverse drug events (ADEs) spontaneously reported to the Danish Medicines Agency on quetiapine used in the pediatric population in relation to adversive drug reactions (ADRs) reported in the European Summary of Product Characteristics (SPCs). The ADE report database at Danish Medicines Agency was searched for all quetiapine ADRs involving individuals (<18 years) in the period 1997-2015. Fifteen ADE case reports were retrieved, scrutinized, and categorized. The average age was 14.8 years (range 10-17 years) and six patients were boys. The main reported ADEs were (i) endocrine, for example, hyperprolactinemia and hyperthyroidism, (ii) cardiac, for example, tachycardia and QT prolongation, (iii) neurological, for example, seizures and cerebral hemorrhage, and (iv) psychiatric, for example, hallucinations. As some of the reported ADEs are life threatening and not listed as ADRs in the SPCs, off-label use of quetiapine in children and adolescents gives rise to safety concerns. SN - 1473-5857 UR - https://www.unboundmedicine.com/medline/citation/27685179/Adverse_events_in_children_and_adolescents_treated_with_quetiapine:_an_analysis_of_adverse_drug_reaction_reports_from_the_Danish_Medicines_Agency_database_ L2 - http://dx.doi.org/10.1097/YIC.0000000000000148 DB - PRIME DP - Unbound Medicine ER -