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...
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