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Panel Questions Antipsychotics for Kids

Nov 20, 2008 | Parker Waichman LLP

Reuters is reporting that a panel of external experts is urging the U.S. Food and Drug Administration (FDA) and “other U.S. health agencies” to look at “the long-term effects” of antipsychotic drugs on children.

The group met to review the safety of Risperdal—known generically as risperidone, and manufactured by Johnson & Johnson—and Zyprexa—manufactured by Eli Lilly and Company  and known generically as olanzapine, reported Reuters.  Reuters said the panel, which met this week, “unanimously requested more long-term data on the side effects of using these drugs in children.”  Both medications are atypical antipsychotics and have made headlines for their increased and unapproved use in children, said Reuters.

"These drugs have very high potential for benefit but also have a fairly well recognized set of risks," Dr. Carl D'Angio, of the University of Rochester in Rochester, New York, and a panel member, quoted Reuters. 

Risperdal, which is prescribed to treat schizophrenia, has been linked to diabetes, neuroleptic malignant syndrome (NMS), tardive dyskinesia, no less than 37 reports of stroke or stroke-like events, and 16 deaths.  Risperdal has also been known to cause irregular heartbeats, muscle weakness and spasms, high fever, constipation, weight gain and headaches. 

Zyprexa, another popular schizophrenia medication, has been linked to serious side effects including diabetes, hyperglycemia, and other blood sugar disorders.  One study that included both drugs found them to cause diabetes 50 percent more often than older antipsychotics.

Reuters noted that close to 400,000 Risperdal prescriptions - 25 percent of all those written for the drug -  were filled for children and teenagers last year.  Of those, 240,000  went to children under age of 12.  In children  under age 17, the drugs were used most often to given to children with  autism and ADHD.

Reuters also reported that based on “documents submitted to the panel,” in the years “between 1993 and March 2008, some 1,200 children on” Risperdal experienced “severe side effects,” with 31 ending in death. 

“We are concerned about some of the side effects that they have because these drugs affect multiple organ systems," Dr. Keith Kocis, a panel member from the University of North Carolina at Chapel Hill, told Reuters. 

According to Reuters, FDA spokeswoman Sandy Walsh said the panel was “surprised” to learn that such a “high percentage” of Risperdal's “total usage is in children,” adding that the committee was concerned with its off-label use in children with ADHD.  Reuters quoted Walsh as saying in an email that the agency would be meeting with the National Institutes of Health (NIH) "to discuss long-term study of drugs in this class and will begin looking closely at specifically how these products are actually being used in treating pediatric patients and their effects."

It is widely accepted and understood that doctors can use their best judgment in prescribing practices and can prescribe FDA-approved drugs for approved and nonapproved purposes.  However, as Reuters points outs, some doctors are pushing this freedom, especially in the case of antipsychotics and children.

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