Wednesday, June 10, 2009
FDA panel backs antipsychotic drugs for kids
An FDA advisory panel has concluded that three antipsychotic drugs already widely used in children--Zyprexa, Seroquel, and Geodon--are safe and effective in treating children with bipolar disorder or schizophrenia, according to news reports.
The FDA is late to the game here--combined sales of the three drugs reached $10 billion last year, according to Reuters.
The drugs are approved only for adults, not for children. But doctors can legally prescribe them for children.
The advisory panel, made up of experts outside the FDA, cautioned that the long-term effects of the drugs on children is unknown. No long-term studies have been done.
That's of particular concern in children, who might have to take the drugs for a lifetime.
The FDA can now consider whether to approve the drugs for children, which would allow the drugs' makers to begin actively marketing them for children--something the companies cannot do now.