Label Changes for:

Symbyax (olanzapine and fluoxetine HCl)

October 2011

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2011

 

 

ADVERSE REACTIONS

Additional Findings Observed in Clinical Studies

Sexual Dysfunction

  • There are no adequate and well-controlled studies examining sexual dysfunction with Symbyax or fluoxetine treatment. Symptoms of sexual dysfunction occasionally persist after discontinuation of fluoxetine treatment...
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