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Risperidone Approved for Schizophrenia in Children
> 9/25/2007 10:01:47 AM

The FDA has approved Risperidone to treat children for schizophrenia and the manic episodes of bipolar disorder. This is a momentous decision, because Risperidone will be the first atypical antipsychotic ever approved to treat children with those two illnesses. While some doctors are still worried about the dangers of atypical antipsychotics, these newer drugs are considered less likely to cause the very common and devastating movement malfunctions tardive dyskinesia and tardive akathisia. Anything that can save children from lifelong spasms and discomfort is good news.

Atypical antipsychotics have been given to children off-label for many years. Once a medication is approved by the FDA for use in the United States, as Risperidone was in 1993, doctors are allowed discretion to employ it outside the intended use according to their professional judgement. This practice sometimes allows experts to give their patients the best treatment ahead of bureaucratic decisions, but it also allows for a disorganized system where the best method of treatment is hard to identify. Fortunately, the official approval given to Risperidone will aid the construction of clear and unified guidelines for treatment.

The approval process was facilitated by the Best Pharmaceuticals for Children Act (BPCA). The BPCA gives incentives to pharmaceutical companies to conduct experiments in crucial areas of pediatric medication. In exchange for an extended patent, Janssen conducted two Risperidone experiments. The first test, designed to observe schizophrenia symptoms, tested 417 children aged 13 to 17. Any dosage over .15 milligrams a day ameliorated symptoms far better than the placebo. In the second test, designed to monitor bipolar symptoms, .5 mg/day was enough to ameliorate manic episodes more effectively than the placebo. These tests are important because they show that dosages over the minimum do not necessarily confer increased benefit but do increase the risk of unpleasant side-effects. Doctors who have been prescribing off-label can now use this research to plan treatment for children more effectively.

Risperidone has not been cleared of all risks; FDA approval is not a magical absolution. A prior study found that 14% of patients gain 20 pounds after using Risperidone for 8 months, and there has been some concern over elevated prolactin levels. 20 pounds, as inconvenient as they may be, hardly move the scale when a lifetime of spasms is weighed against them. Despite residual concerns, doctors can now be confident that Risperidone is helpful and of relatively low risk for children.

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