Label Changes for:
Symbyax (olanzapine and fluoxetine hydrochloride) capsules
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.