Examining risperidone use in those diagnosed with autism 1 year after FDA approval.

To the Editor: Within the past 3 years, the US Food and Drug Administration (FDA) approved risperidone for the treatment of irritability (which includes behaviors such as aggression, selfinjury, and temper tantrums) associated with autism in children and adolescents 5 to 16 years of age. This approval was the first of its kind and was given in part on the basis of the results of clinical trials completed with individuals with autism demonstrating effectiveness for its use with this population (ie, decrease in irritability, aggression, and self-injurious behavior).1–3 And, the limited research that has been conducted evaluating the use of antipsychotics in treating those with autism supports the use of risperidone over other typical antipsychotic medications such as haloperidol.4 However, recent published articles have raised concerns regarding the use of risperidone since the FDA’s approval.5,6 Specifically, some of the concerns raised include the use of antipsychotic medication to treat aggressive behaviors in those with intellectual disabilities and a paucity of measures for determining the effectiveness of antipsychotic drug use in those with autism (eg, multiple arm studies, agreement on diagnostic criteria for autism, equivalent dose ranges). Given the concerns raised by others regarding risperidone use in those with autism, collecting information regarding the prevalence of use of risperidone is important in that it potentially informs us about the appropriate and possibly inappropriate uses of risperidone for this population. The purpose of this project was to determine what changes if any have occurred in the use of risperidone by individuals diagnosed with autism and/or intellectual disabilities (as individuals with intellectual disabilities are prescribed risperidone for irritability as well) in the State of Iowa since the FDA approved its use for the treatment of autism symptoms in October 2006 and to prompt further and closer evaluation of risperidone use on a larger scale.