FDA Clears Abilify for Use in Teens with Bipolar Disorder
By Anna Boyd
17:13, March 3rd 2008
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FDA Clears Abilify for Use in Teens with Bipolar Disorder

The U.S. Food and Drug Administration cleared Abilify (aripiprazole) Friday for treatment of bipolar disorder in adolescents, the Wall Street Journal reports.

Abilify, manufactured by Bristol-Myers Squibb Co. and Japanese partner Otsuka Pharmaceutical Co., was first approved in November 2002 for the acute and maintenance treatment of certain kinds of bipolar I disorder in adults and for schizophrenia in people 13 and older.

Bipolar I Disorder is a mood disorder, characterized by at least one manic or mixed episode. There may be episodes of hypomania or major depression as well. The disease is a sub-diagnosis of bipolar disorder, and conforms to the classic concept of manic-depressive illness.

On Friday, Bristol-Myers and Otsuka said the FDA approved the supplemental New Drug Application for Abilify for certain episodes associated with bipolar I disorder in patients 10- to 17-years-old.

Abilify offers a potential advantage over other atypical antipsychotic drugs because “it doesn’t cause to the same degree weight gain and metabolic” disorder, said Jeffrey Lieberman, chairman of psychiatry at Columbia University in New York, in a telephone interview yesterday, according to The Star-Ledger.

“The major problem with second-generation antipsychotic drugs is weight gain and diabetes. The younger you are, the more severe and common these side effects,” Lieberman said.

According to a study in the Archives of General Psychiatry released in September, the number of American children diagnosed with bipolar disorder jumped 40-fold from 1994 to 2003. By 2003, the diagnosis was applied to 1 in 100 kids, researchers found.



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