Abilify Approved for Autism Symptoms in Children


Abilify (aripiprazole) has been approved by the Food and Drug Administration (FDA) as a treatment for irritability in children ages 6 to 17 who have autism. The announcement was made by Bristol-Myers Squibb, which makes Abilify.

Autism is a complex developmental disorder that affects approximately 1 percent of children in the United States. According to the Autism Society of America, the lifetime cost of caring for a child who had autism ranges from $3.5 to 5 million, and the United States faces about $90 billion annually in costs for the disorder. There is no cure for autism, and treatment generally involves a combination of medical, psychological, social, and educational components.

Both Bristol-Myers and Otsuka Pharmaceutical Company are collaborators on the development and distribution of Abilify in the United States and Europe, and noted in their press release that the new indication for the drug is intended to be part of a more comprehensive treatment plan. Current treatments for autism can include various antidepressants, antipsychotic drugs, and stimulants designed to address difficult behaviors and symptoms; nutrients, including vitamin B complex; avoidance of certain foods because of possible food allergies; and educational and behavioral therapies and interventions.


The decision to treat a child who has autism with Abilify should be made between the healthcare provider and the caregivers after the child has undergone a thorough diagnostic evaluation and the risks and benefits of the drug are understood by the caregivers. The American Psychiatric Association has guidelines that recommend routine assessment and monitoring of patients who take aripiprazole to watch their weight, blood pressure, and the development of any metabolic adverse effects.

Abilify was approved for children with autism based on data from two eight-week, randomized, double-blind, placebo-controlled, multi-center studies. The drug was shown to significantly improve aggression toward others, deliberate self-injury, temper tantrums, and quickly changing moods.

Thus far, experts do not have data on how long patients treated with Abilify should keep taking the medication for maintenance treatment. Therefore children with autism who are prescribed this drug need to be reassessed periodically, and parents and caregivers should report any changes in behavior or symptoms that are disturbing once treatment with Abilify has begun. Side effects may include nausea, vomiting, headache, constipation, sleeplessness, dizziness, and tremors.

Autism Society of America
Bristol-Myers Squibb news release, Nov. 20, 2009


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