FDA APPROVAL OF RISPERIDONE GETS MIXED REVIEWS FROM AUTISM EXPERTS
Should neurologists consider the antipsychotic risperidone (Risperdal) for treating irritability, aggression, temper tantrums, deliberate self-injury, and other problem behaviors in autistic children and adolescents?
The Food and Drug Administration's (FDA) first-time approval of the drug for that indication last month would seem to answer “yes.” But in interviews with Neurology Today, leading autism experts expressed mixed response to that decision. The take-home message: proceed with caution.
Fred Volkmar, MD, Professor of Child Psychiatry, Pediatrics, and Psychology at Yale University School of Medicine, said: “This is an appropriate, and somewhat overdue, action on the part of the FDA. The large federally funded RUPP [Research Units on Pediatric Psychopharmacology] study showed very convincingly that the drug was very helpful for the agitation that often is observed in autism.” Dr. Volkmar was the original principal investigator of the Yale research site.
Risperidone was reported to be efficacious and safe for treating irritability, aggression, hyperactivity, and stereotypy in autistic children, but it was less effective for treating the core symptoms of autism, according to several clinical trials between 1992 and 2006 (Ann Pharmacother 2006;40:909–916) and a key study in the New England Journal of Medicine (2002;347:314–321).
James T. McCracken, MD, of the University of California-Los Angeles, and colleagues at other RUPP sites conducted two eight-week, placebo-controlled trials in 156 patients aged 5 to 16 years. Compared to controls, children taking risperidone had significantly improved scores for behavioral symptoms of autism.
Nancy Minshew, MD, Professor of Psychiatry and Neurology at the University of Pittsburgh School of Medicine, told Neurology Today, however, that the drug could have “serious side effects” and she stressed that clinicians should consider behavioral intervention first.
Risperidone can cause tardive dyskinesia and severe movement disorders on withdrawal after long-term use.
“This kind of drug should never be used casually, without careful differential diagnosis of the underlying cause of the behavior, and careful use of all other alternatives,” said Dr. Minshew.
Isabelle Rapin, MD, Professor of Neurology and Pediatric Neurology at the Albert Einstein College of Medicine in New York, added that she would not prescribe risperidone for children unless the irritability and aggressiveness were severe. “At this time there is no sure way to detect children who are susceptible to these serious side effects [tardive dyskinesia and movement disorders],” Dr. Rapin said.
Risperidone has been approved for the short-term treatment of schizophrenia in adults since 1993, and for the short-term treatment of adults with acute manic or mixed episodes associated with extreme mood swings since 2003.