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Affymax, Inc. Message Board

  • dinepat203 dinepat203 Mar 5, 2013 6:54 PM Flag

    EPOGEN HISTORY -VOLUNTARY RECALL AND HEALTHCARE PROFESSIONAL INFORMATION

    November 2010: Correction to Recall Update and HCP Recall Notification
    October 2010: Recall Update and Recall information for Pharmacists
    September 2010: Voluntary Product Recall Notice and HCP Notification

    LETTERS TO HEALTH CARE PROFESSIONALS
    June 2011: Updated Aranesp® (darbepoetin alpha) and EPOGEN®/PROCRIT® (epoetin alpha)United States Prescribing information (USPI) for patients with chronic kidney disease (CKD)
    December 2009: Aranesp® (darbepoetin alfa) and EPOGEN®/PROCRIT® (epoetin alfa) Label Change based on TREAT Results Showing an Increased Risk of Stroke in Chronic Renal Failure Patients Not on Dialysis with Anemia and Type 2 Diabetes Treated to a Hemoglobin of 13 g/dL
    April 2009: Reports of antibody-mediated pure red cell aplasia and transfusion-dependent anemia in patients with Hepatitis C virus (HCV) infection treated with ribavirin and interferon or pegylated interferon and an erythropoiesis-stimulating agent (ESA) concurrently
    August 2008: Strengthened Oncology Safety Information and New Medication Guide and Patient Instructions for Use for EPOGEN®/PROCRIT® and Aranesp®
    March 2008: Additional Trials Showing Increased Mortality and/or Tumor Progression with EPOGEN®/PROCRIT® ?and Aranesp®
    November 2007: Increased Mortality, Serious Cardiovascular and Thromboembolic Events, and Tumor Progression with?EPOGEN®/PROCRIT® and Aranesp®
    March 2007: IMPORTANT DRUG WARNING and NEW PRESCRIBING INFORMATION

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