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FDA Panel OKs Newer Antipsychotics for Children
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Page: << Prev | 1 | 2 | 3 | Next >> 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 heartbeat, difficulty sleeping and trouble concentrating.
Ronald T. Brown, dean and professor of public health at Temple University Health Sciences Center, testified before the panel. Speaking to HealthDay before the panel voted, he said there was still too little known about the efficacy and side effects of these medications in children for the FDA to approve their use in kids.
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"The problems are what we don't know rather than what we do know," Brown said. "We don't know anything about the long-term effects of these medications; they have only been through a six-week trial."
"I am not convinced about the long-term safety of these drugs," he added.
"Particularly with children, when you don't know, I don't think you should approve it," Brown said. "In this country, we are very overzealous to approve drugs. I think we need to be more conservative, particularly because this is a pediatric population."
Brown believes off-label use may be safe, because it is done for particular patients, with the family's consent. "That's a lot different than saying this drug has been approved for children and adolescents," he said.
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.
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Copyright © 2009 ScoutNews, LLC. All rights reserved.
Last updated 6/11/2009
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SOURCES: David Fassler, M.D., clinical professor, psychiatry, University of Vermont College of Medicine, Burlington; Diana Zuckerman, Ph.D.,
president, National Research Center for Women & Families, Washington, D.C.; Ronald T. Brown, Ph.D., dean and professor, public health, Temple University Health Sciences Center, Philadelphia; June 10, 2009, statement, U.S. Food and Drug Administration; June 10, 2009, statement, AstraZeneca, Wilmington, Del.
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