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December 7, 2009

FDA Approves Zyprexa for Bipolar Adolescents

The U.S. Food and Drug Administration (FDA) has approved Zyprexa (olanzapine) for treatment of schizophrenia and manic/mixed episodes associated with Bipolar I disorder in adolescents aged 13-17 years. This approval, announced on Dec. 4, comes with plenty of warnings for would be users of the drug.

The updated Zyprexa label states that clinicians should take into consideration the increased potential for weight gain and hyperlipidemia in adolescents compared to adults and the potential for long-term risks, which in many cases, may lead them to consider prescribing other drugs first in adolescents. For additional reference review our Oct. 28 blog which discusses a widely reviewed Journal of the American Medical Association study which found that teens are more prone to weight gain when taking atypical antipsychotic drugs than adults.

An FDA Psychopharmacologic Drug Advisory Committee (PDAC) met in June and discussed the difficulties of diagnosing and treating these conditions in adolescents. The Zyprexa label provides additional guidance to physicians that medication therapy for pediatric schizophrenia or bipolar I disorder should be initiated only after a thorough diagnostic evaluation and careful consideration of the risks associated with medication treatment. The FDA said it will examine the weight-gain side effect in children at a hearing next week.

With Friday's announcement Zprexa joins Seroquel (See Dec 6 blog), Abilify and Risperdal as atypical antipsychotics that are now FDA approved for children and/or adolescents.

Zyprexa is manufactured by Eli Lilly and was their top-selling medication in 2008, with sales of $4.7 billion

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