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U.S. Department of Health and Human Services

Safety

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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

 

Summary View

BOXED WARNING

  • 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

MEDICATION GUIDE

  • 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
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