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FDA To Determine Approval For Antipsychotics In Children

June 5, 2009

The US Food and Drug Administration announced on Friday that it is investigating the approval of three popular antipsychotic drugs for children.

The three drugs, currently marketed for adult use by AstraZeneca, Pfizer and Eli Lilly and Co, appear to be beneficial in children and adolescents, but FDA regulators said they must determine if the drugs pose a greater risk to younger patients.

An agency panel is set to meet next week in order to weigh the risks of the psychiatric drugs in children between the ages of 10 and 17.

FDA officials are concerned about possible health risks linked to the drugs due to the length of treatment in children who begin taking them at an early age. Some doctors already prescribe the drugs to children and adolescents, although the medications are not currently approved for such use.

“These risks are of particular concern in pediatric patients because of the lifelong nature of these disorders,” said FDA director for psychiatric products, Dr. Thomas Laughren.

The Associated Press reported data from IMS Health that showed the three drugs – approved to treat schizophrenia and bipolar mania in adults ““ had combined sales of more than $7.4 billion last year.

“Schizophrenia and bipolar disorder are serious illnesses in pediatric patients and represent substantial burden for both patients and their families,” Laughren said.

AstraZeneca is hoping to gain permission to market Seroquel to adolescents with schizophrenia and bipolar mania. Lilly is seeking to market its drug Zyprexa for the same disorders, while Pfizer hopes to market its drug Geodon.

“We generally are in agreement that the sponsors have provided adequate support to suggest effectiveness,” he added.

The agency will seek insight from outside sources during next week’s meeting. The agency is not required to follow the group’s advice, though it usually does, according to the Associated Press.

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