Alerts
Olanzapine (Zyprexa, Zyprexa Zydis) - Use with Caution in Adolescents
February 1, 2010
FDA and Lilly have revised the product labeling of olanzapine (Zyprexa, Zyprexa Zydis) to address its use in adolescents. In December 2009, oral olanzapine was approved for the treatment of schizophrenia and bipolar disorder in patients between the ages of 13 and 17 years old. Approval for use in adolescents was based on a single 3-week trial for bipolar disorder and a single 6-week trial for schizophrenia. The intramuscular formulation is labeled only for use in adults.
The starting dose of oral olanzapine for adolescents is lower than that for adults. Compared with adults, some adverse effects of olanzapine are more common and more severe in adolescents, including weight gain, sedation, hyperlipidemia, increased prolactin, and increased liver function tests. These adverse effects may increase the long-term risks of therapy, especially in patients with preexisting diabetes, lipid disorders, or hepatic disease. Clinicians are encouraged to consider therapy with other agents before prescribing oral olanzapine for adolescents. When administered to these patients, use oral olanzapine as part of a comprehensive treatment program, in conjunction with psychological, educational, and social interventions.
Additional information is available at the following links:
- MedWatch Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm198402.htm - Dear Healthcare Professional Letter:
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/UCM198412.pdf - Revised Product Label:
http://www.accessdata.fda.gov/drugsatfda_docs/label/ 2010/020592s052,021086s031,021253s037lbl.pdf
Updated
February 1, 2010; University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.
