A US Food and Drug Administration advisory committee has cleared three blockbuster antipsychotics as treatments for schizophrenia and bipolar disorder in paediatric and adolescent populations.

The FDA’s Psychopharmacologic Drugs Advisory Committee will decide on whether AstraZeneca's Seroquel (quetiapine), Pfizer's Geodon (ziprasidone) and Eli Lilly's Zyprexa (olanzapine), which are widely prescribed off-label, can be promoted for use in children. The panellists said the data provided by the companies showed that the atypical antipsychotics are effective and “reasonably safe” for younger patients.

For Seroquel, AstraZeneca is looking to market the drug for schizophrenia in patients aged 13 to 17, and for bipolar disorder in youngsters aged 10 to 17. The committee voted pretty much unanimously in favour, despite a few abstentions, for both age groups and indications.

As for Lilly’s drug, for the proposed schizophrenia indication (13-17 years old), the panel voted 11-5, with two abstentions, that Zyprexa's effectiveness had been demonstrated, and voted 10-4, with four abstentions, that these data demonstrated acceptable safety. For manic or mixed episodes associated with bipolar I disorder in the same age group, the panel voted 17-0, with one abstention, on effectiveness and 11-4, with three abstentions, on safety.

The committee expressed concerns about adverse reactions such as sedation, weight gain, increases in blood fats and sugars and tardive dyskinesia. John Hayes, vice president of Lilly Research Laboratories, noted that because some metabolic changes are more likely in adolescents compared to adults, “we agreed with the FDA that in many cases other available treatment options should be considered before Zyprexa when treating adolescents”,

The panellists were a little less enthusiastic about Geodon and voted 8 to 1, with nine abstentions, that the drug is safe for 10 to 17 year-olds with bipolar disorder. The abstaining members of the committee were concerned that Pfizer had provided incomplete data.

The committee also noted that it is worried about the lack of long-term studies on the drugs, but its recommendations now make approvals from the FDA highly likely.