FDA advisory committee yesterday called 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. The committee said antipsychotics are increasingly prescribed to children, often for unapproved uses, such as treating attention deficit disorders or ADHD.

Last year more than 389,000 children were given Johnson & Johnson’s Risperdal, of whom 240,000 were 12 or younger to treat attention deficit disorders. The panel members said that Risperdal is not approved for that use and its risks - weight gain, metabolic disorders and possibly permanent muscular tics - aren’t justified.

Leon Dure, a pediatric neurologist from the University of Alabama School of Medicine and panel member, told the meeting, “This committee is frustrated.” Adding that “And we need to find a way to accommodate this concern of ours.”

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

Children and teens now make up nearly 25 percent of all patients who fill a prescription for Risperdal and according to documents submitted to the panel 1,200 children on the drug had severe side effects and 31 children died between 1993 and March 2008. Dr. Keith Kocis, a panel member from the University of North Carolina at Chapel Hill said, "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."

Sandy Walsh, a spokeswoman for the FDA said 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 said, "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."

Tom Laughren, director of the FDA’s division of psychiatry products said, “I’m a little puzzled about the statement that the label is inadequate. I’m anxious to hear what more we can do in the labeling.” He said medical specialty societies must do a better job educating doctors about side effects.