Procrit is a drug that treats anemia by increasing the number of red blood cells. 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 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
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