Advisers urge FDA to address antipsychotics in kids

GAITHERSBURG, Maryland Thu Sep 22, 2011 6:54pm EDT

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GAITHERSBURG, Maryland (Reuters) - 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.

The pediatric advisory committee voted 16-1 to support the U.S. Food and Drug Administration's routine safety monitoring of the new generation of antipsychotics.

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

"We ask that with this upcoming revision that you carefully consider the language around pediatric use and adverse events," said Dr. Geoffrey Rosenthal, the committee's chair and director of Pediatric and Congenital Heart Center at the University of Maryland Medical Center.

The FDA in the next month to six weeks will release a revised label for Abilify, sold by Bristol-Myers Squibb Co and Otsuka Pharmaceutical, which is one of the antipsychotic drugs approved for use in children.

The new label will detail the drug's latest clinical trials, warn of metabolic concerns and remind doctors to monitor patient weight and symptoms of diabetes, said Dr. Tom Laughren, FDA's psychiatry products chief.

The new generation of antipsychotic medications has raised a wave of concerns as they are increasingly being prescribed for a host of uses and for younger and younger patients, with little conclusive research addressing their impact on children and sometimes with little evidence they work.

Newer antipsychotics include Johnson & Johnson's Risperdal, known generically as risperidone; Eli Lilly & Co's Zyprexa or olanzapine; AstraZeneca's Seroquel or quetiapine; and Abilify, known generically as aripiprazole.

U.S. researchers have found that the drugs' use in children increased by 65 percent from 2002 to 2009, primarily through prescriptions for teenagers.

From fall 2009 to spring of this year, 1.9 million prescriptions were written for patients under 18, most commonly for bipolar disorder in teenagers and toddlers aged 3 to 6, and for affective psychoses in children between the ages of 7 and 12.

(Reporting by Alina Selyukh; Editing by Tim Dobbyn)

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