Label Changes for:

Arimidex (anastrozole) Tablets, 1 mg

May 2013

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)

 

May 2013

6.0 ADVERSE REACTIONS

6.2 Post-Marketing Experience
  • hypercalcemia (with or without an increase in parathyroid hormone) added to trigger finger
  • added.....myalgia

NOTE: revised the text throughout the entire patient package insert

 

April 2011

 

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Other Adverse Reactions

  • ...safety results from ATAC trial...

 

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