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FDA, Eli Lilly Announce Olanzapine Labeling Changes

Last Updated: February 01, 2010.

On Jan. 29, the U.S. Food and Drug Administration and the pharmaceutical company Eli Lilly announced changes to the prescribing information for olanzapine (Zyprexa).

MONDAY, Feb. 1 (HealthDay News) -- On Jan. 29, the U.S. Food and Drug Administration and the pharmaceutical company Eli Lilly announced changes to the prescribing information for olanzapine (Zyprexa).

According to the drug's revised labeling, clinicians who are deciding what to prescribe adolescents for bipolar I disorder or schizophrenia should consider the increased potential for weight gain and hyperlipidemia associated with olanzapine. Compared to adults, these risks are increased in adolescents.

The revised labeling also states the need for a comprehensive treatment program -- perhaps including psychological, educational and social components -- in pediatric patients with schizophrenia or bipolar I disorder, and notes that olanzapine is an integral part of this program. In addition, it states that the drug's safety and efficacy have not been established in pediatric patients younger than 13 years of age.

"As in adults, potential consequences of weight gain should be considered prior to starting olanzapine in adolescents. Patients receiving olanzapine should have their weight monitored regularly. In olanzapine-treated adolescent patients, both the magnitude of weight gain and the proportion of patients who had clinically significant weight gain were greater than in adult patients with comparable exposures," Donald Therasse, M.D., vice president of global patient safety at Eli Lilly, said in a statement.

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