US panel urges study of antipsychotics in children

CHICAGO Nov 19 (Reuters) - A panel of outside experts is calling on the U.S. Food and Drug Administration and other U.S. health agencies to study the long-term effects of prescribing powerful antipsychotic drugs to children.

In what had been scheduled as a routine review of the safety of Johnson & Johnson's (JNJ.N) drug Risperdal, or risperidone, and Eli Lilly and Co's (LLY.N) Zyprexa, or olanzapine, the panel on Tuesday unanimously requested more long-term data on the side effects of using these drugs in children.

The drugs, known as atypical antipsychotics, are increasingly being prescribed to children for unapproved uses, such as attention deficit hyperactivity disorder, or ADHD.

"These drugs have very high potential for benefit but also have a fairly well recognized set of risks," Dr. Carl D'Angio, a panel member from the University of Rochester in Rochester, New York, said in a telephone interview on Wednesday.

Those side effects include muscular tics, rapid weight gain and increased risk for diabetes.

"The panel felt the FDA should continue to try to explore the risk-benefit ratio and continue to provide us with information about the risks and try to get as good a handle as they can on the subgroups in which adverse events occur," D'Angio said.

While doctors are free to prescribe any FDA-approved drug they see fit, some panel members raised concerns that doctors are going too far, and on far too little data supporting their safety in children.

AUTISM, ADHD TREATMENT

Children and teens now make up nearly 25 percent of all patients who fill a prescription for Risperdal.

Last year, nearly 400,000 children and teens used the drug, and almost 240,000 were aged 12 or younger. For those under age 17, the most common diagnoses were autism and ADHD.

Between 1993 and March 2008, some 1,200 children on the drug had severe side effects and 31 children died, according to documents submitted to the panel.

"This drug is shown to be effective and helpful for children. 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, said in a telephone interview.

Sandy Walsh, a spokeswoman for the FDA, noted that the panel found no new safety issues with the drugs, but said the independent advisers were surprised to hear that a high percentage of Risperdal's total usage is in children.

And she said there was concern expressed by the committee about off-label use of the drug in children with ADHD.

Walsh said in an e-mail the FDA will meet with the National Institutes of Health "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."

Dr. John March, chief of child and adolescent psychiatry at Duke University Medical Center in Durham, North Carolina, who is not on the panel, said there is a lack of data on drugs used in children.

"The advisory panel was right in highlighting the main issue, which is that we simply don't known across the range of applications of atypical antipsychotics which kids will benefit by using these drugs and which kids will be harmed," March said in a telephone interview. (Editing by Will Dunham and Eric Walsh)