Three more antipsychotic drugs may soon be marketed for kids and adolescents, if an FDA advisory panel's recommendation is adopted by the agency. Eli Lilly's Zyprexa got a cautious thumbs-up as a second-line bipolar and schizophrenia treatment. Pfizer's Geodon was deemed effective in children 10 to 17, though its long-term safety is tough to gauge because of high dropout rates in pediatric studies, the panel said.
It was AstraZeneca's Seroquel, though, that was the biggest winner of the day: The committee backed Seroquel as a first-line bipolar and schizophrenia treatment, saying it was "acceptably safe" for use in kids and adolescents. Currently, Johnson & Johnson's Risperdal and Bristol-Myers Squibb's Abilify are the only atypicals approved for pediatric use.
The panel experts--and other observers--advised caution, however. As a class of meds, atypical antipsychotics have spurred serious weight gain in certain patients, and they've been linked to diabetes and other serious side effects. Plus, long-term safety data in kids isn't available for any of them. So the FDA should keep close tabs on the meds' usage and safety in pediatric patients, they said. "We should have the broadest range of [treatment] options that we can," David Shern, who testified before the advisory panel, told the Wall Street Journal Health Blog. But post-market surveillance and clinical practices need to improve so that "kids that need drugs get access to them, and the kids that don't, don't," he said.
These meds already are used off-label to treat serious psychiatric illness. In fact, the use of antipsychotics--approved and unapproved--in children and adolescents doubled from 2001 to 2008, as the Health Blog points out. They're commonly used among adults, too; for the first time, antipsychotics topped U.S. drug sales last year with $14.6 billion in annual revenue, Bloomberg reports.
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- check out the coverage in the Health Blog
ALSO: AstraZeneca scored another victory in its legal battle against thousands of plaintiffs claiming that the antipsychotic drug Seroquel caused their diabetes. A Delaware judge dismissed a liability case because he was unconvinced by an expert witness's assertion that the drug triggered the plaintiff's disease. Report