Monday, September 26, 2011

U.S. Advisers Urge FDA to Address Antipsychotics in Kids


U.S. pediatric health advisers on Thursday urged drug regulators to continue studying weight gain and other side-effects of antipsychotic drugs as they are increasingly taken by children.

Significant numbers of U.S. children are receiving drugs to tame aggression, attention deficit disorder and other mental problems, even though there is little conclusive data to show exactly how the medications work or whether they damage kids' health


The pediatric advisory panel on Thursday listened to preliminary results of a study sponsored in part by the FDA that, inconclusively still, compared whether some antipsychotic drugs put children at a higher risk of developing diabetes than others.

Similar to the recommendations the panel has made in previous years, it voted 16-1 to support the U.S. Food and Drug Administration's routine safety monitoring of the new generation of antipsychotics.

But the panel did so with a caveat that the agency specifically look at how to clarify the drugs' labels to highlight concerns about their impact on children, namely the risks of weight gain and diabetes.

"There is serious concern that children may be at a higher risk for serious adverse effects and we just don't have sufficient data to answer that question," said Dr. Jonathan Mink, a child neurology expert from the University of Rochester Medical Center.

Read more: http://www.foxnews.com/health/2011/09/23/us-advisers-urge-fda-to-address-antipsychotics-in-kids/#ixzz1Z4NLIjrf

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