
In briefing documents posted to the FDA's website, agency staff recommended that the regulator conduct further study of the potential impacts of antipsychotic drug use in children.
A review of medical literature found a link between treatment with these drugs and adverse metabolic effects, such as weight gain, in younger patients, they explained.
Regarding the metabolic side effects, the reviewers stated: "Although observational studies have limitations, this hypothesis should nonetheless be subject to some further evaluation by the agency.
" They cited results from a study published in JAMA recently, which showed that children treated with antipsychotics gained up to 19 pounds in 11 weeks depending on the drug prescribed. The findings from this and other studies merit further evaluation with "robust clinical data," the FDA staff suggested.
In addition, the reviewers said an FDA analysis showed an increase in reports of metabolic problems with Eli Lilly's Zyprexa (olanzapine) and AstraZeneca's Seroquel (quetiapine). The staff indicated that these findings "by themselves may not reflect true agent-specific differences in risk."
The FDA's paediatric advisory panel is scheduled to discuss antipsychotic drug issues at a meeting on December 8.