Friday, June 5, 2009

Antipsychotic drugs appear to work in kids: FDA staff

Three antipsychotic drugs appear to work in children and teens but their risks must be weighed as the makers seek to promote them for younger patients, the head of the U.S. Food and Drug Administration's psychiatric division said in a memo released on Friday.

The FDA has yet to make a final decision on whether to approve drugs made by AstraZeneca, Pfizer and Eli Lilly and Co for children and teens with schizophrenia or bipolar disorder.

An FDA panel is to meet next week to give recommendations on the companies' bid to promote the drugs for children and teenagers with schizophrenia or bipolar disorder.

Doctors can already prescribe the medications for children, but FDA approval would allow the manufacturers to market them more widely.

The drugs, known as atypical antipsychotics, are widely used to treat various psychiatric conditions but have come under scrutiny for links to weight gain.

"We generally are in agreement that the sponsors have provided adequate support to suggest effectiveness," FDA's Thomas Laughren wrote in the memo released on Friday.

He added that the safety of the drugs in children appeared "to be qualitatively similar to those observed with these drugs in adult patients."


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