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.

FDA panel criticizes use of antipsychotics in kids

An FDA expert panel says it is concerned that antipsychotic drugs are being overused in children, the New York Times reports today.

The committee said that more than 389,000 children and teens were treated last year with Risperdal, one of a class of drugs known as atypical antipsychotics, which were thought to have fewer side-effects that traditional antipsychotics. Of those who received the drug, 240,000 were less than 13 years old, the committee was told.

The Bush FDA wants to continue routine monitoring of the safety of these drugs. But the committee rebelled. "This committee is frustrated. And we need to find a way to accommodate this concern," said panel member Dr. Leon Dare of the University of Alabama School of Medicine.

The problem with routine monitoring--this is me talking, not the committee--is that there really isn't such a thing. Doctors are supposed to report problems to the FDA, and the FDA is supposed to compile those reports and watch for evidence of problems. But doctors often don't see the problems, or don't report them if they do. And the FDA has few resources to pursue these reports.

"Monitoring" suggests to me an active process: Actively following children on the meds, or a representative sample of them, systematically collecting data, and assessing risks. That is what I understand by "monitoring."

The FDA's idea of monitoring is passive, and ineffective.