title: Neurological, Metabolic, and Psychiatric Adverse Events in Children and Adolescents Treated With Aripiprazole.
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: 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.
authors: Klaus Damgaard
authors: KD
authors: Jakobsen
authors: Christina Hedegaard
authors: CH
authors: Bruhn
authors: Anne-Katrine
authors: AK
authors: Pagsberg
authors: Anders
authors: A
authors: Fink-Jensen
authors: Jimmi
authors: J
authors: Nielsen
mesh_terms: D000293:Adolescent; D014150:Antipsychotic Agents / Q000009:adverse effects*; D000068180:Aripiprazole / Q000009:adverse effects*; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy; D000067877:Autism Spectrum Disorder / Q000188:drug therapy; D002648:Child; D002675:Child, Preschool; D016208:Databases, Factual; D003718:Denmark; D064420:Drug-Related Side Effects and Adverse Reactions / Q000503:physiopathology*; D005260:Female; D006801:Humans; D008297:Male; D065886:Neurodevelopmental Disorders / Q000188:drug therapy*; D009771:Obsessive-Compulsive Disorder / Q000188:drug therapy*; D011618:Psychotic Disorders / Q000188:drug therapy*; D012559:Schizophrenia / Q000188:drug therapy*; D005879:Tourette Syndrome / Q000188:drug therapy
chemical_list: D014150:Antipsychotic Agents; D000068180:Aripiprazole