In October 2006, the FDA approved the use of Risperdal (risperidone), an anti-psychotic medication, for the treatment of irritability in autistic children and young adults. Up until then, the drug had been approved only for use in adults, but was still apparently often prescribed off-label for children.
Since then, a number of plaintiffs have brought claims against manufacturer Janssen Pharmaceuticals and parent company, Johnson & Johnson, claiming they failed to warn about the serious side effects associated with Risperdal, including abnormal breast growth in boys (gynecomastia).
The Simons Foundation Autism Research Initiative (SFARI) recently reported on an informal analysis of the drug’s use in autistic children, and warned that Risperdal may help some children, but that it can have “severe side effects.”
Studies Show Risperdal Effective
Studies have indicated that Risperdal can help treat disruptive behavioral symptoms in autistic children, as well as in youths with other developmental disorders. In 2004, for example, researchers gave either Risperdal or a placebo to 79 children aged 5 to 12 years old who had so-called “pervasive developmental disorders (PDD).” Results showed that those taking the drug exhibited a 64 percent improvement over baseline in the irritability score—almost double that of those taking the placebo. Risperdal was also affective against anxiety, hyperactivity, and oversensitivity.
A later 2005 study found similar results. Researchers examined children and adolescents with autism, giving them either Risperdal or placebo. They found that compared to placebo, the drug led to a significantly greater reduction in maladaptive behaviors like severe temper tantrums, aggression, and self-injurious behavior. Such effects could help children to receive more benefits from social services and educational programs.
But What About Side Effects?
The SFARI calls Risperdal a double-edged sword, calming tantrums and aggression in some children, but causing significant side effects. One of these is weight gain. According to studies, the drug increases appetite, resulting in an increased intake in calories.
A2002 study, for example, found that while Risperdal helped calm disruptive behaviors, it also resulted in an average weight gain of nearly 3 pounds over the study period, compared with not even one in those taking a placebo. Other noted side effects included increased appetite, fatigue, drowsiness, dizziness, and drooling. Such disruptions—especially when children are tired in school—could negate any positive benefits the drug has on behavior.
According to the SFARI, researchers have also found that “after six weeks of taking a standard dose of risperidone, children had greater increases in insulin levels and insulin resistance than children taking a placebo,” indicating a potential increase in risk for diabetes.
Other Studies Show Overuse in Children
This isn’t the first warning about the potential dangers of using Risperdal in children. In a study recently published in the Journal of Child and Adolescent Psychopharmacology, researchers reported that Risperdal has been overprescribed in foster children suffering from ADHD—a condition for which the FDA has not approved the drug. After researching data on over 260,000 young people in foster care aged 2 to 17, results showed that antipsychotics like Risperdal were used to treat nearly one-third of them.
In addition to fatigue and weight gain, Risperdal has also been linked with increased prolactin levels (a hormone responsible for breast growth), and tardive dyskinesia (movement disorder).