Adelphi, Maryland - With varying degrees of enthusiasm, a Food and Drug Administration advisory committee Wednesday concluded that three newer antipsychotic drugs already widely used "off-label" in children and teens are "acceptably safe" and effective in treating them for schizophrenia and bipolar disorder.

However, because of the risks involved with the drugs - mainly weight gain, sleepiness and increases in blood fats and sugars - several panel members expressed concerns about their inappropriate use in pediatric patients who don't have schizophrenia or bipolar disorder or are younger than the age range studied.

"I'm a little concerned ... that soon we'll be seeing 4-, 5- and 6-year-olds treated with these agents," said Kenneth Towbin, a psychiatrist with the National Institute of Mental Health who specializes in children and adolescents.

AstraZeneca's Seroquel, Pfizer's Geodon and Eli Lilly's Zyprexa are approved for schizophrenia and bipolar disorder in adults. Two other antipsychotic drugs, Risperdal and Abilify, are approved for those conditions in patients under 18. "I think everybody agrees that we want more medications, rather than fewer," said panelist Gail Griffith, a consumer representative from Washington, D.C.

The committee's votes on the safety and efficacy of Seroquel as an acute treatment for schizophrenia in patients 13 to 17 were virtually unanimously positive, with two abstentions on safety and one "no" on efficacy.

There were 18 voting members. There were varied reasons for abstentions, some coming from panelists who aren't specialists in child and adolescent psychiatry.

Panelists voted 17 to 0 with one abstention that Seroquel is effective in treating bipolar mania in patients 10 to 17. The vote on its safety for this use was 13 "yes" and five abstentions.

On Geodon's effectiveness in treating bipolar mania in patients 10 to 17, 12 panelists voted "yes." Two voted "no," and four abstained. On whether Geodon is safe for that use, eight voted "yes," one voted "no" and nine abstained. Geodon is not a proposed treatment for schizophrenia.

On whether Zyprexa is effective in treating schizophrenia in 13- to 17-year-olds, the vote was 11 "yes," five "no" and two abstentions. Ten said it's safe; four said it isn't; four abstained.

All but one panelist, who abstained, said Zyprexa is effective for treating bipolar mania in patients 13 to 17, but only 11 said it's safe, while four said it isn't and three abstained.

Although the FDA isn't required to follow advisory panel recommendations, it usually does. Approving the drugs for pediatric use allows the agency to provide information about proper use on the label, said the FDA's Thomas Laughren.