NeLM news service
Revised US labelling of olanzapine (Zyprexa®) regarding safety in adolescents

Source: FDA

Date published: 01/02/2010 15:44

Summary
by: Nicola Pocock

Lilly and the FDA have notified healthcare professionals in the US of changes to the prescribing information for olanzapine (Zyprexa®), related to its use in adolescents (licensed for the treatment of schizophrenia and bipolar I disorder [manic or mixed episodes] in those aged ages 13-17).

 

The revised labelling notes that clinicians should consider the increased potential in adolescents (as compared with adults) for weight gain and hyperlipidaemia, and the potential long-term risks associated with olanzapine use, when deciding among the alternative treatments available for this age group.  In many cases this may lead them to consider prescribing other drugs first in adolescents.

 

In addition, text regarding the need for a comprehensive treatment program in paediatric patients has been added to Section 17.14, as follows: “Zyprexa is indicated as an integral part of a total treatment program for paediatric 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 paediatric patients less than 13 years of age”.

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