The side effects ‘ EPS ’ , ‘ parkinsonism ’ , and ‘ tremor ’ were significantly more common in children and adolescents treated with aripiprazole than in those treated with placebo .
Conclusion Our meta- analysis provides evidence for a non-negligible incidence of acute EPS in children and adolescents treated with aripiprazole .
Background Both the US FDA and the European Medicines Agency ( EMA ) have approved aripiprazole for use in adolescents for specific indications .
Given the assumed favorable side-effect profile of aripiprazole , its use in children and adolescents has increased for both official and off-label indications ( anxiety disorders , eating disorders , personality disorders ) .
However , several cases of children and adolescents with new-onset  extrapyramidal symptoms ( EPS )  after commencing treatment with aripiprazole have been reported , and a more systematic appraisal of this possible risk is lacking .
Objective We conducted a systematic review and a meta- analysis to assess the evidence for acute EPS ( acute dystonia , akathisia , Parkinsonism ) associated with the use of aripiprazole in children and adolescents .
Safety and tolerability of aripiprazole for irritability in pediatric patients with autistic disorder: a 52-week, open-label, multicenter study.
OBJECTIVE Evaluate the long-term safety and tolerability of aripiprazole in the treatment of irritability in pediatric subjects ( 6 - 17 years ) with autistic disorder . METHOD A 52-week , open-label , flexibly dosed ( 2 - 15 mg/d ) study of the safety and tolerability of aripiprazole in out patients with a DSM-IV-TR diagnosis of autistic disorder who either had completed 1 of 2 antecedent , 8-week r and omized trials or were enrolled de novo ( ie , not treated in the r and omized trials ) .  Safety and tolerability measures included incidences of adverse events , extrapyramidal symptoms , weight , metabolic measures , vital signs , and other clinical assessment s. RESULTS Subjects were enrolled between September 2006 and June 2009 . Three hundred thirty subjects entered the treatment phase : 86 de novo , 174 prior aripiprazole , and 70 prior placebo . A total of 199 ( 60.3 % ) subjects completed 52 weeks of treatment . Adverse events were experienced by 286/330 subjects ( 86.7 % ) . Common adverse events included weight increase , vomiting , nasopharyngitis , increased appetite , pyrexia , upper respiratory tract infection , and insomnia . Discontinuations due to adverse events occurred in 35/330 r and omized subjects (10.6%)-most commonly aggression and weight increase . One patient discontinued from the study due to a laboratory-related adverse event ( moderately increased alanine transaminase and aspartate transaminase ) . Nine subjects experienced serious adverse events-most frequently aggression . Extrapyramidal symptoms-related adverse events occurred in 48/330 subjects (14.5%)-most commonly tremor ( 3.0 % ) , psychomotor hyperactivity ( 2.7 % ) , akathisia ( 2.4 % ) , and dyskinesia ( not tardive , 2.4 % ) . At > 9 months ' aripiprazole exposure ( n = 220 ) , mean change in body weight z score was 0.33 and body mass index z score was 0.31 . The percentages of subjects with clinical ly significant fasting metabolic abnormalities at > 9 months were 2 % for glucose , 5 % for total cholesterol , 7 % for low-density lipoprotein cholesterol , 30 % for high-density lipoprotein cholesterol , and 5 % for triglycerides . CONCLUSIONS Aripiprazole was generally safe and well tolerated in the long-term treatment of irritability associated with autistic disorder in pediatric subjects . Weight should be proactively monitored during long-term treatment . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00365859
The side effects ‘ EPS ’ , ‘ parkinsonism ’ , and ‘ tremor ’ were significantly more common in children and adolescents treated with aripiprazole than in those treated with placebo .
Conclusion Our meta- analysis provides evidence for a non-negligible incidence of acute EPS in children and adolescents treated with aripiprazole .
Background Both the US FDA and the European Medicines Agency ( EMA ) have approved aripiprazole for use in adolescents for specific indications .
Given the assumed favorable side-effect profile of aripiprazole , its use in children and adolescents has increased for both official and off-label indications ( anxiety disorders , eating disorders , personality disorders ) .
However , several cases of children and adolescents with new-onset  extrapyramidal symptoms ( EPS )  after commencing treatment with aripiprazole have been reported , and a more systematic appraisal of this possible risk is lacking .
Objective We conducted a systematic review and a meta- analysis to assess the evidence for acute EPS ( acute dystonia , akathisia , Parkinsonism ) associated with the use of aripiprazole in children and adolescents .