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 .
Paediatric Atypical Antipsychotic Monitoring Safety (PAMS) Study
Abstract Background : In the UK , treatment with  antipsychotic medications  for children is usually initiated by specialists in secondary care . Recent studies have shown an increase in the prescribing of atypical antipsychotics in children . The severity of possible adverse effects to antipsychotics in adults has lead to awareness of the importance of investigating the potential adverse effects of these agents in children . Additionally , there have been many reports proposing that the newer atypical antipsychotics are associated with many of the same adverse effects seen with the older generation drugs in children . The aim of the Paediatric Atypical Antipsychotic Monitoring Safety ( PAMS ) study was to determine the feasibility of conducting a prospect i ve targeted pharmacovigilance study to monitor adverse drug reactions ( ADRs ) associated with atypical antipsychotic therapy in children seen in secondary - and tertiary-care setting s. Methods : Participants were identified from the clinical members of the UK Paediatric Psychopharmacology Groups in London and the West Midl and s. Participating clinicians reported the number of patients ( aged ≤18 years ) taking atypical antipsychotic treatment who were under their care and any reportable ADRs experienced by these patients during the period September 2006–September 2007 . Participants contributed data via password protected online data collection forms . Results : A total of 35 clinicians consented to participate in the study . However , data from 22 of the participating clinicians were excluded because of incomplete reporting . Data from the remaining 13 ( 37 % ) clinicians were eligible for the final analysis . There were 281 patients who received atypical antipsychotic treatment under the care of the 13 participating clinicians . From these 281 patients , 40 ADR reports ( 0.14 ADR reports per patient ; 95 % CI 0.10 , 0.19 ) from 37 patients were entered into the data base . Of the 37 patients , 13 experienced more than one ADR , bringing the total number of ADRs to 56 ( 0.20 ADR per patient ; 95 % CI 0.15 , 0.25 ) . The most commonly reported ADRs were weight gain , extrapyramidal symptoms and hyperprolactinaemia . Rare ADRs , including neuroleptic malignant syndrome , were also reported . The duration s of atypical antipsychotic drug exposure were recorded for 54 of the 56 ADRs reported . The median duration of exposure was 42 days ( interquartile range 23.25–90 days ) . Conclusions : Our study demonstrates that a clinician-based targeted pharmacovigilance study on  atypical antipsychotics in children provides useful qualitative data . However , this pilot study raised many method ological issues , which should be addressed for the study to be extended nationally . Specifically , significant funding is needed to improve the reporting rate and the overall data obtained . Furthermore , the study yielded a very high incidence of serious ADRs , thus supporting the need for a larger and improved pharmacovigilance study to evaluate the safety of atypical antipsychotics in children
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 .