Label Changes for:
Symbyax (olanzapine and fluoxetine HCL) Capsules
April 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) – April 2011
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Additional Findings Observed in Clinical Studies
Nervous System
- ...depersonalization...
- Other Adverse Reactions Observed with Olanzapine or Fluoxetine Monotherapy multiple adverse reactions added
6.2 Vital Signs and Laboratory Studies
- Extensive changes to laboratory changes section
8 USE IN SPECIAL POPULATIONS
8.1 Pregnancy
- ...Symbyax section added
- ...Fluoxetine section modified
17 PATIENT COUNSELING INFORMATION
17.18 Use in Specific Populations
Pregnancy
- ...Symbyax should be...
