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Neurological, Metabolic, and Psychiatric Adverse Events in Children and Adolescents Treated With Aripiprazole.
J Clin Psychopharmacol. 2016 Oct; 36(5):496-9.JC

Abstract

Aripiprazole is a partial dopamine agonist with only minor neurological and psychiatric adverse effects, making it a potential first-line drug for the treatment of psychiatric disorders. However, the evidence of its use in children and adolescents is rather sparse. The aim of this case study is to discuss adverse drug reaction (ADR) reports concerning aripiprazole-associated neurological and psychiatric events in children and adolescents. The ADR report database at Danish Medicines Agency was searched for all ADRs involving children and adolescents (<18 years) reported by the search term [aripiprazole] AND all spontaneous reports since the introduction of aripiprazole in 2003 until December 31, 2015. Nineteen case reports were included in the study and included both patients with psychotic disorders (PS group) and nonpsychotic disorders (non-PS group). The PS group consisted of 5 patients with schizophrenia and psychoses, not otherwise specified; and the non-PS group consisted of fourteen cases including autism spectrum disorders, attention deficit and hyperactivity disorder, obsessive-compulsive disorder, and Tourette syndrome. The main reported adverse effects in the non-PS group were chronic insomnia, Parkinsonism, behavioral changes psychoses, and weight gain, whereas the adverse effects in the PS group was predominantly anxiety, convulsions, and neuroleptic malignant syndrome. Although aripiprazole is considered safe and well tolerated in children and adolescents, severe adverse events as neuroleptic malignant syndrome, extreme insomnia, and suicidal behavior has been reported to health authorities. Clinicians should pay attention to these possible hazards when prescribing aripiprazole to this vulnerable group of patients.

Authors+Show Affiliations

From the *Department of Clinical Medicine, Aalborg University; †Department of Psychiatry, Aalborg University Hospital, Aalborg; ‡Danish Medicines Agency, Copenhagen; §Centre for Child and Adolescent Mental Health, Mental Health Services; ∥Mental Health Centre Copenhagen, Department O, Capital Region of Denmark; and ¶Faculty of Health Sciences of Copenhagen University, University of Copenhagen, Copenhagen, Denmark.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27504593

Citation

Jakobsen, Klaus Damgaard, et al. "Neurological, Metabolic, and Psychiatric Adverse Events in Children and Adolescents Treated With Aripiprazole." Journal of Clinical Psychopharmacology, vol. 36, no. 5, 2016, pp. 496-9.
Jakobsen KD, Bruhn CH, Pagsberg AK, et al. Neurological, Metabolic, and Psychiatric Adverse Events in Children and Adolescents Treated With Aripiprazole. J Clin Psychopharmacol. 2016;36(5):496-9.
Jakobsen, K. D., Bruhn, C. H., Pagsberg, A. K., Fink-Jensen, A., & Nielsen, J. (2016). Neurological, Metabolic, and Psychiatric Adverse Events in Children and Adolescents Treated With Aripiprazole. Journal of Clinical Psychopharmacology, 36(5), 496-9. https://doi.org/10.1097/JCP.0000000000000548
Jakobsen KD, et al. Neurological, Metabolic, and Psychiatric Adverse Events in Children and Adolescents Treated With Aripiprazole. J Clin Psychopharmacol. 2016;36(5):496-9. PubMed PMID: 27504593.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Neurological, Metabolic, and Psychiatric Adverse Events in Children and Adolescents Treated With Aripiprazole. AU - Jakobsen,Klaus Damgaard, AU - Bruhn,Christina Hedegaard, AU - Pagsberg,Anne-Katrine, AU - Fink-Jensen,Anders, AU - Nielsen,Jimmi, PY - 2016/8/10/entrez PY - 2016/8/10/pubmed PY - 2017/4/30/medline SP - 496 EP - 9 JF - Journal of clinical psychopharmacology JO - J Clin Psychopharmacol VL - 36 IS - 5 N2 - Aripiprazole is a partial dopamine agonist with only minor neurological and psychiatric adverse effects, making it a potential first-line drug for the treatment of psychiatric disorders. However, the evidence of its use in children and adolescents is rather sparse. The aim of this case study is to discuss adverse drug reaction (ADR) reports concerning aripiprazole-associated neurological and psychiatric events in children and adolescents. The ADR report database at Danish Medicines Agency was searched for all ADRs involving children and adolescents (<18 years) reported by the search term [aripiprazole] AND all spontaneous reports since the introduction of aripiprazole in 2003 until December 31, 2015. Nineteen case reports were included in the study and included both patients with psychotic disorders (PS group) and nonpsychotic disorders (non-PS group). The PS group consisted of 5 patients with schizophrenia and psychoses, not otherwise specified; and the non-PS group consisted of fourteen cases including autism spectrum disorders, attention deficit and hyperactivity disorder, obsessive-compulsive disorder, and Tourette syndrome. The main reported adverse effects in the non-PS group were chronic insomnia, Parkinsonism, behavioral changes psychoses, and weight gain, whereas the adverse effects in the PS group was predominantly anxiety, convulsions, and neuroleptic malignant syndrome. Although aripiprazole is considered safe and well tolerated in children and adolescents, severe adverse events as neuroleptic malignant syndrome, extreme insomnia, and suicidal behavior has been reported to health authorities. Clinicians should pay attention to these possible hazards when prescribing aripiprazole to this vulnerable group of patients. SN - 1533-712X UR - https://www.unboundmedicine.com/medline/citation/27504593/Neurological_Metabolic_and_Psychiatric_Adverse_Events_in_Children_and_Adolescents_Treated_With_Aripiprazole_ L2 - http://dx.doi.org/10.1097/JCP.0000000000000548 DB - PRIME DP - Unbound Medicine ER -