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UPDATE 1-US FDA panel has child weight concerns about drug
December 8, 2009 / 11:45 PM / 8 years ago

UPDATE 1-US FDA panel has child weight concerns about drug

(Adds details)

ROCKVILLE, Md., Dec 8 (Reuters) - A U.S. drug regulatory advisory panel said on Tuesday current labeling for pediatric uses of Bristol-Myers Squibb Co’s (BMY.N) antipsychotic drug, Abilify, does not adequately warn of the risk of excessive weight gain.

The panel also recommended they continue to monitor pediatric use of the drug, known by the generic name of aripiprazole.

The panel voted 12-0 that the current label was inadequate and FDA staff were to work on a revised label, which staff said might include moving all information on metabolic effects of the drug in children to the warning section. Other metabolic effects could include development of type 2 diabetes or metabolic syndrome.

Abilify is used to treat schizophrenia and bipolar disorder. (Reporting by Jackie Frank; editing by Andre Grenon)

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