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Changes have been made to the prescribing information for olanzapine (Zyprexa, Eli Lilly) related to its indication for use in adolescents (ages 13 - 17 years) for the treatment of schizophrenia and bipolar I disorder, the US Food and Drug Administration (FDA) announced on Friday.
The wording, described in an alert sent last week from MedWatch, the FDA's safety information and adverse event reporting program, encourages clinicians to consider potential long-term risks when prescribing to adolescents.
The changes update information pertaining to the recent FDA approval of the use of oral olanzapine in adolescents (ages 13 - 17 years) in December 2009, as reported by Medscape Medical News .
Two sections have been modified: section 1, the indications and usage section, and section 17.14, "a Need for Comprehensive Treatment Program in Pediatric Patients."
In section 1, the wording states, "when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia. Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents."
In section 17.14, the wording states that olanzapine "is indicated as an integral part of a total treatment program for pediatric patients with schizophrenia and bipolar disorder that may include other measures (psychological, educational, social) for patients with the disorder. Effectiveness and safety of ZYPREXA have not been established in pediatric patients less than 13 years of age."
More information is available on the FDA's MedWatch Web site.
Adverse events related to olanzapine should be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.
