FDA Panel Deems Three Psychiatric Drugs Safe, Effective In Kids
A Food and Drug Administration advisory committee voted Wednesday to recommend that three psychiatric drugs be approved for use in children.
The panel made up of outside experts said that Seroquel, Geodon and Zyprexa appear safe and effective to treat bipolar disorder and schizophrenia in children as young as 10. The medications are already approved for use in adults and may be prescribed to children, though they are not specifically approved for such use.
The vote on Wednesday amounts to a recommendation only. The FDA typically follows the advice of its advisory panels, but does not have to.
Advertisement - Continue Reading Below
Approval would allow the drugs’ makers to market the medications to this new demographic.
While the advisory panel voted overwhelmingly in favor of using the three drugs known as atypical antipsychotics in children, there are significant concerns about side effects like sedation and weight gain. Plus, little is know about the long-term impact the drugs may have.