Aripiprazole for Irritability Associated with Autistic Disorder in Children and Adolescents Aged 6–17 Years

Kelly Blankenship; Craig A Erickson; Kimberly A Stigler; David J Posey; Christopher J McDougle


Pediatr Health. 2010;4(4):375-381. 

In This Article

Regulatory Affairs

Aripiprazole was recently approved by the FDA for use in children and adolescents aged 6–17 years for treatment of irritability associated with autistic disorder. The FDA has approved the use of aripiprazole up to 15 mg/day (initial dose 2 mg/day; recommended dose 10 mg/day) in autistic children and adolescents.[104] Previously, the FDA placed a black box warning on all atypical antipsychotics, including aripiprazole, for use in treatment of dementia-related psychosis. Elderly individuals treated with atypical antipsychotics for dementia-related psychosis are at an increased risk of death compared to those treated with placebo.[2] The FDA has also placed a black box warning on all products with an indication for MDD, including aripiprazole. Children, adolescents and young adults taking antidepressants for MDD and other psychiatric disorders are at increased risk of suicidal thinking and behavior when compared to placebo.


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