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FDA Panel Mulls Newer Antipsychotics for Kids
Date:6/10/2009

d AstraZeneca to add a special "black box" warning to Seroquel's packaging, outlining increased risks of hyperglycemia, high blood pressure and diabetes associated with use of the drug. Also, older patients with dementia-related psychosis treated with Seroquel are at an increased risk of death, according to the FDA.

And in a unanimous vote in early April, an FDA advisory panel determined that Seroquel should not be approved as first-line therapy for adult depression, because of continued questions about its safety profile -- most notably, a link to higher risk for sudden cardiac death. However, the drug was approved for use in patients for whom other antidepressants didn't work.

The family of atypical antipsychotics has other well-documented potential side effects, including weight gain and high blood sugar, which can increase the risk of diabetes, as well as rapid heart beat, difficulty sleeping and trouble concentrating.

Prior studies have also found that these newer drugs are no more effective than older medications. Their main advantage is that they do not cause the tremors and muscle spasms associated with older agents.

Cost is an issue, as well: According to the Associated Press, these newer drugs are patent-protected and costs range between $300 to $500 per month, compared with about $100 per month for older antipsychotics.

There's also concern about the rapid increase in the use of these medications in pediatric populations in the absence of adequate research on long-term safety and efficacy, Fassler said.

"None of these medications should be used without careful considerations of the risks and benefits," Fassler said. "Children and adolescents taking these medications should be monitored closely for evidence of significant side effects or adverse reactions. Nonetheless, when used appropriately, these medications can be a helpful and effective component of treatment for children and
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