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Page: << Prev | 1 | 2 | 3 Diana Zuckerman, president of the National Research Center for Women & Families, a Washington, D.C.-based advocacy group, believes much more study is needed before good decisions can be made as to the use of these antipsychotics by youngsters.
According to Zuckerman, the small studies that are out there suggest that, while on these drugs, "between 20 to 30 percent of kids were gaining weight, heart rates were increased, many of the kids were so knocked out [sedated] that they could barely function."
Overall, the trials submitted to the FDA panel were small, Zuckerman added, noting there were "usually less than 100 at a specific dosage."
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"If you want to prove that the benefits outweigh the risks," she said, "it is necessary to study thousands of kids for at least a year in double-blind studies, preferably longer. These studies don't come close to doing that."
Fassler took a more measured view.
"None of these medications should be used without careful consideration of the risks and benefits," he 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 adolescents with schizophrenia or bipolar disorder."
In any case, drugs should never be viewed as the only therapeutic option open to young patients, according to Fassler.
"Medication, including the atypical antipsychotics, can be helpful to control some of the signs and symptoms associated with these disorders, but medication alone is rarely an adequate or sufficient intervention. It should only be used as part of a comprehensive treatment plan, individualized to the needs of the child and family," Fassler said.
Dr. Howard Hutchinson, chief medical officer of AstraZeneca, issued the following statement after the panel's endorsement of Seroquel: "We are pleased that the committee found Seroquel to be effective and acceptably safe for treating adolescents with schizophrenia and children and adolescents with bipolar mania, and we look forward to having further discussions with the FDA regarding the sNDAs [supplemental new drug applications]."
Although the FDA isn't required to follow advisory committee recommendations, it usually does.
More information
For more information on atypical antipsychotics, visit the U.S. Food and Drug Administration .
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