Risperidone (Risperdal) for ADHD and ODD: Caution Still Advised Despite New Studies

Risperidone (Risperdal) is an antipsychotic medication typically used for schizophrenia.  It is currently prescribed to a growing minority of children and youth with ADHD, with the most current estimate at about 11.4% in the United States.  While risperidone falls into the category of nonstimulants, it has many differences from other nonstimulant drugs.  Risperidone is typical prescribed for children who have problems with aggression, but since its effectiveness is based on small studies, it has many potentially serious side effects, and it has safer alternatives, it should be used only as a last resort.

Effectiveness

Risperidone currently is not FDA approved for any purpose in children except for irritability due to autism.  It is not FDA approved as safe and effective for use in children who have ADHD or ODD.  A recent review in the Canadian Journal of Psychiatry noted that the evidence that risperidone is effective for disruptive behavior disorders in children is limited to children of lower than average IQ.  There have been no trials of risperidone in normally developing children with ADHD or ODD. 

In a press release on November 4, 2013, US Department of Justice announced that it had filed a complaint against Janssen Pharmaceuticals alleging that between 1999-2005 the company marketed Risperdal as safe and effective for symptoms of several childhood behavioral disorders, including ADHD and ODD.  The allegations included telling doctors who spoke for the company that in order to be paid, they would have to increase their prescriptions for Risperdal. 

Since then, two studies have been published about the use of risperidone in children with ADHD.  One study was done in children who were treated for various problems with risperidone, including conduct disorder.  In this study, there was some improvement noted in symptoms of conduct disorder, sleep disorders, and lack of appetite.  There was one case of dyskinesia (abnormal movements) in this study.   The other study, funded by the NIH,  was done in children with severe aggressive behaviors (such as severe ODD and conduct disorder) and ADHD.  This study noted improvement of such behaviors with risperidone, with the main trade offs being elevated prolactin and upset stomach, although some patients also gained a minimal amount of weight.  These studies were both small and short term.

Doctors are allowed to prescribe risperidone "off label" , that is, for non-FDA approved indications, but usually this is only approved in experimental situations, or for intractable cases, when clinical studies have shown some indication of effectiveness.

Side effects

The Canadian Journal of Psychiatry review also noted that physicians may be under the mistaken impression that risperidone does not require monitoring.  However Risperdal's prescribing information notes that monitoring for several complications is important, including tardive dyskinesia (an irreversible disorder that results in uncontrollable, unplanned movements) , elevated blood glucose/diabetes, weight gain, cholesterol related disorders, blood cell abnormalities, and high prolactin levels.  Monitoring these types of complications would require at minimum an interview, physical examination and blood tests.

Risperidone's effects do not wear off as quickly as stimulant drugs do.  As noted above, tardive dyskinesia can be permanent.

When is it ok to use risperidone for ADHD or ODD?

• The child has irritability and autism, and is over the age of 5.  Risperidone is FDA approved for this use.
• The child is older than 5 and of lower than average IQ and FDA approved methods of controlling aggression have been exhausted.  Any FDA approved medication for ADHD can curb aggression due to ADHD. Clonidine is also frequently prescribed for aggression and has a better safety profile than risperidone.
• There is a significant suspicion for schizophrenia, and the doctor has discussed other available treatments.  Of note, schizophrenia typically does not manifest in children and should be diagnosed by a psychiatrist.
• Risperidone is used for bipolar disorder, but usually after other, more effective  medications have been tried.
• A child of normal IQ with ADHD and/or ODD should never be prescribed risperidone for control of aggression unless all other avenues (FDA approved medication, medication with more clinical trial evidence of effectiveness in children with ADHD,  psychological counseling/training) have been exhausted and the doctor is willing to provide the necessary monitoring for what is still  experimental therapy.  In this type of situation, a specialist should be consulted and possibly a second opinion obtained.

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