Evidence-based recommendations for monitoring safety of second-generation antipsychotics in children and youth.

BACKGROUND The use of antipsychotics, especially second-generation antipsychotics (SGAs), for children with mental health disorders in Canada has increased dramatically over the past five years. These medications have the potential to cause major metabolic and neurological complications with chronic use. OBJECTIVE To synthesize the evidence for specific metabolic and neurological side effects associated with the use of SGAs in children, and provide evidence-based recommendations for the monitoring of these side effects. METHODS A systematic review of controlled clinical trials of SGAs involving children was performed. Recommendations for monitoring SGA safety were made according to a classification scheme based on the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. When there was inadequate evidence, recommendations were based on consensus and expert opinion. A multidisciplinary consensus group reviewed all relevant evidence and reached consensus on the recommendations. RESULTS The present guidelines provide evidence-based recommendations for monitoring SGA safety. The strength of recommendations for specific physical examination manoeuvres and laboratory tests are provided for each SGA medication at specific time points. CONCLUSION Multiple randomized controlled trials evaluated the efficacy of many of the SGAs in paediatric mental health disorders. These benefits, however, are not without risks - both metabolic and neurological side effects occur in children treated with SGAs. The risk of weight gain, increased body mass index and abnormal lipid levels is greatest with olanzapine, followed by clozapine and quetiapine. The risk of neurological side effects of the treatment is greatest with risperidone, olanzapine and aripiprazole. Appropriate monitoring procedures for adverse effects will improve the quality of care of children treated with these medications.