The drug Abilify has received federal approval for treatment of irritability and aggression in children with autism, the drug’s makers say.
The U.S. Food and Drug Administration recently approved Abilify for children ages 6 to 17-years-old who have autism and struggle with aggression towards others and themselves, temper tantrums and quickly changing moods, according to the Bristol-Myers Squibb Company and Otsuka Pharmaceutical Company who jointly produce the drug.
The approval is based on two studies in which caregivers reported that children with autism were significantly less irritable after taking Abilify as compared to a placebo. However, study participants taking Abilify did experience more weight gain across the board than those taking the placebo. And they were more likely to experience side effects including sedation, fatigue, fever and drooling.
Abilify was previously approved for treatment of depression, bipolar disorder and Schizophrenia. When used with children who have autism, the drug should be used in conjunction with psychological, educational and social interventions, the companies said in a statement.
