Label Changes for:

Symbyax (olanzapine and fluoxetine hydrochloride) capsules

August 2009

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2009

WARNINGS AND PRECAUTIONS

Leukopenia, Neutropenia, and Agranulocytosis: 
  • Class Effect — In clinical trial and/or postmarketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents, including Symbyax. Agranulocytosis has also been reported.
  • Patients with a history of a clinically significant low white blood cell count (WBC) or drug induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of Symbyax should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
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