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Procrit Warning

Procrit is a drug that treats anemia by increasing the number of red blood Procritcells. Procrit is manufactured by Amgen Inc. and marketed by a Johnson & Johnson subsidiary, Ortho Biotech. The FDA approved Procrit in 1999 to treat patients with cancer, kidney failure, HIV, and patients undergoing major surgery. Unfortunately, Procrit has been linked to several serious and fatal side effects. This prompted the FDA to require Johnson & Johnson to add a black box warning to Procrit’s label.

FDA’s March 2007 Procrit Warning

In March 2007, the FDA ordered Johnson & Johnson to add a black box warning to Procrit’s label. A black box warning is the most severe action the FDA can take besides a recall. The warning states that patients with kidney disease are susceptible to heart problems or death if the hemoglobin level exceeds 12 g/dL (grams (g) per deciliter (dL)). The

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warning also states that patients with head and neck cancer or breast cancer have an increased risk of death when taking Procrit. The warning label also states cancer patients should use Procrit only if receiving chemotherapy. 

FDA’s November 2007 Procrit Warning  

In November 2007, the FDA instructed Johnson & Johnson to revise the black box warnings on Procrit’s label. The revised warnings relate to patients with cancer and patients with chronic kidney failure.

Procrit Warning for Cancer Patients 

The black box warning for cancer patients provides that:

  • Using Procrit to achieve hemoglobin levels above 12 g/dl has resulted in quicker cancer progressions and shorter survival time in patients with the following cancers:
     Advanced breast
     Head and neck
     Lymphoid
     Non-small cell lung malignancies
  • The risks of quicker cancer progressions and shorter survival times were not ruled out in cancer patients who are receiving chemotherapy when Procrit is used to reach hemoglobin levels below 12 g/dL
  • Procrit should only be used to treat anemia that occurs in cancer patients during chemotherapy treatment
  • Procrit use should stop when chemotherapy ends

Procrit Warning for Kidney Failure Patients

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

  • The risk of death and severe cardiovascular events (including heart attacks and stroke) increases when Procrit dosage is administrated to achieve higher hemoglobin levels
  • Procrit dosage should achieve and maintain hemoglobin levels between 10 g/dL and 12 g/dL

Information on Procrit Warnings
If you would like more information about Procrit or its warnings, please contact us today.



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    Procrit Quick Facts

    Procrit Quick Reference Guide
    Other Names:

    epoetin alfa

    Date Approved:
    1999

    Manufacturer:
    Amgen Inc.

    Marketer:
    Johnson & Johnson

    Status:
    Black Box Warning

    Approved Uses:
    Anemia

    Serious Side Effects:
    Blood Clots
    Heart Attacks
    Stroke
    Death

    Common Misspellings:
    Procret
    Procrot