Amgen Inc. manufactures Epogen to treat anemia. In July 1999, the Food and Drug Administration (“FDA”) approved Epogen to treat anemia in patients with cancer, kidney disease, HIV, and patients requiring major surgery. Unfortunately, Epogen is linked to many severe and fatal side effects, including blood clots, heart attacks, and strokes. This prompted the FDA to order Amgen to add a black box warning to Epogen’s label.
FDA’s March 2007 Epogen Warning
In March 2007, the FDA ordered Amgen to add a black box warning to Epogen’s label. The FDA’s black box warning order is the most severe action it can take besides a recall. The warning must state that Epogen users with kidney disease are susceptible to heart problems (and even death) if hemoglobin levels exceed 12 g/dL (grams (g) per deciliter (dL)). The label must also include a warning about an increased death risk for Epogen users with head and neck or breast cancer. Lastly, the label must warn cancer patients to use Epogen only if receiving chemotherapy treatment.
FDA’s November 2007 Epogen Warning for Kidney Disease Patients
In November 2007, the FDA ordered Amgen to update the black box warnings on Epogen’s label. The updated warning label for Epogen users with kidney disease provided that:
- Using Epogen to achieve higher hemoglobin level increases the risk of death and severe cardiovascular events (including heart attack and vascular thrombosis)
- Epogen dosage should achieve and maintain hemoglobin levels between 10 g/dL and 12 g/dL
FDA’s November 2007 Epogen Warning for Cancer Patients
The FDA ordered Amgen to update Epogen’s black box warnings for cancer patients to include warnings that:
- Epogen use to achieve hemoglobin levels above 12 g/dl may result in quicker cancer progressions and shorter survival time for patients with the following cancers: -Advanced breast -Head and neck -Lymphoid -Non-small cell lung malignancies
- Quicker cancer progressions and shorter survival times were not ruled out in cancer patients receiving Epogen doses to reach hemoglobin levels below 12 g/dL
- Epogen should only be used to treat anemia caused by chemotherapy treatment
- A patient should stop using Epogen when the patient stops chemotherapy
Information about Epogen Warnings
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