Label Changes for:
Arimidex (anastrozole) tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
17 PATIENT COUNSELING INFORMATION
17.6 Tickling, Tingling or Numbness...section added
Patient Information (MG)
- added...ARIMIDEX may also cause you to have tickling, tingling or numbness of your skin.
6.0 ADVERSE REACTIONS
6.2 Post-Marketing Experience
- hypercalcemia (with or without an increase in parathyroid hormone) added to trigger finger
NOTE: revised the text throughout the entire patient package insert
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Other Adverse Reactions
- ...safety results from ATAC trial...