Epogen/Procrit (epoetin alfa) and Aranesp (darbepoetin alfa)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – July 2011
- WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRANCE
- Chronic Kidney Disease: ...
5 WARNINGS AND PRECAUTIONS
5.1 Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism
- ... multiple changes made. Contact manufacturer for further information
- revisions to the package insert and REMS (i.e., Medication Guide) that derive from CDER’s review of the TREAT trial, conducted in the chronic renal failure patient population