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...
