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Aranesp Warning

Amgen Inc. manufactures and markets Aranesp. In September 2001, theAranesp FDA approved Aranesp to treat anemia in kidney failure patients on dialysis and cancer patients receiving chemotherapy. Unfortunately, Aranesp is linked to several serious and fatal side effects. This prompted the FDA to require Amgen to add a black box warning to Aranesp’s label.

FDA’s March 2007 Aranesp Warning

In March 2007, the FDA ordered Amgen to add a black box warning to Aranesp’s label. A black box warning order is the most significant action the FDA can take short of a recall. The Aranesp warning states that patients with kidney disease are at risk for heart problems or death if hemoglobin levels exceed 12 g/dL (grams (g) per deciliter (dL)). The warning also states that Aranesp users with head and neck cancer or breast cancer are more susceptible to death.

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FDA’s November 2007 Aranesp Warning for Kidney Failure Patients

In November 2007, the FDA ordered Amgen to update the black box warnings on Aranesp’s label. The updated warnings concern Aranesp users with kidney failure and cancer.

The updated black box warning for patients with chronic kidney failure provides that:

  • Administrating Aranesp doses to achieve higher hemoglobin levels increases the risk of death and severe cardiovascular events (including heart attack and vascular thrombosis)
  • Aranesp dosage should achieve and maintain hemoglobin levels between 10 g/dL and 12 g/dL

FDA’s November 2007 Aranesp Warning for Cancer Patients 

The FDA now requires Aranesp’s label to warn cancer patients about the following:

  • Aranesp use to achieve hemoglobin levels above 12 g/dl has resulted in quicker cancer progressions and shorter survival times in patients with the following cancers:
    • Advanced breast
    • Head and neck
    • Lymphoid
    • Non-small cell lung malignancies
  • Aranesp should only be used if the chemotherapy treatment caused the anemia and
  • A patient should stop Aranesp use when the patient stops chemotherapy.


Information about Aranesp Warnings 
If you would like more information about Aranesp or its warnings, please contact us today. If you or a loved one has been injured by Aranesp, please contact us immediately. You may be entitled to compensation for your injuries.
 



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      Aranesp Quick Facts

      Aranesp Quick Reference Guide
      Other Names: 

      Darbepoetin alfa

      Date Approved:
      September 2001

      Manufacturer:
      Amgen

      Status:
      Black box warning

      Approved Uses:
      Anemia

      Serious Side Effects:
      Blood Clots
      Heart Attacks
      Vascular thrombosis
      Convulsions

      Common Misspellings:
      Arenesp
      Aransep
      Aranasp