Risperidone: Two Encouraging Findings 

Autism, in many children affected by this disorder, is accompanied by varying degrees of behavioral disturbances. Self-injurious behavior, aggression and tantrums can seriously hamper parents’ and educators’ ability to help these children make educational progress and to fully include them in activities and settings that may otherwise be very beneficial.  Haloperidol, an antipsychotic agent, had been used successfully to treat behavior problems in this population, but its side effects are grave enough to deter many physicians and parents from using it.  Risperidone (Risperdal) is another antipsychotic with far fewer adverse reactions.  In a study of 101 children with autism and serious behavioral problems (at doses ranging from 0.5mg to 3.5mg daily), researchers found significant improvements in behavioral disturbances of children with autism.  On Risperidone, standard irritability scores are significantly lower (57%) than the reduction in irritability scores for children receiving a control drug (14%).   Common short-term side effects of Risperidone found in this study were increased fatigue, drowsiness, dizziness, and drooling.  

In another study, the long-term safety and efficacy of Risperidone therapy were investigated.  The population in this study was not limited to children with autism.  Rather, the 77 children (ages 5-12) had any one of many disorders that manifested with both disruptive behavior and mental retardation.  Using similar doses of Risperidone to the first study, children were followed for about 48 weeks.  They not only found Risperidone to be effective, but also that it was equally effective for children regardless of their disorder type, level of retardation, presence/absence of attention deficit/hyperactivity, or whether there was concomitant use of psychostimulants.  As with the first study, somnolence was also found to be a side effect but mild and not associated with cognitive deterioration.  In addition to side effects found in the first study, headache and weight gain were commonly found.  
(McCracken et al: N Eng J Med 2002; 347(5):314-321.)

(Turgay A et al:  Pediatrics PediaLink.org 2002: 110(3) pp e34). 

Comment.  Many school nurses are already seeing drugs like Risperidone being prescribed for similar “off-label” uses.  I often don’t discourage school nurses from administering medications that have not been officially authorized for children by the FDA.  The authorization process is so slow and many of these children are in desperate need for help.  In such circumstances, school nurses need more than regular interactions with the parent; it is worthwhile to seek permission for direct interaction with the prescribing physician.  School staff’s impressions of these drugs’ effectiveness and suspicions for any potentially adverse reaction are critically important information.  – H.T.