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Epogen®, Procrit®, and Aranesp®, drugs given to anemia patients suffering from kidney failure, will be taken up by a Food and Drug Administration (FDA) advisory panel. The FDA recently added a black box warning to the products' labels recommending that the drugs be used at the lowest dose possible.

Epogen®, Procrit®, and Aranesp® are all erythropoiesis-stimulating agents (ESAs) given to anemia patients suffering from kidney failure and undergoing chemotherapy treatment. Before the use of these ESAs, such anemia was treated with blood transfusions.

In March the FDA discovered that physicians were using ESAs to increase red blood cell counts to unsafe levels. The new black box warning labels advised that the drugs should be administered at the lowest dose possible in order to bring red blood cell counts to the lowest level necessary to avoid transfusions. The warning labels said red blood cell levels should not be allowed to go above 12 grams per deciliter of blood, but did not specify what the lowest level should be.

The FDA has not pinpointed a proper dosing for ESAs, however a review of the drugs' safety found that more research focusing on proper dosing is needed. Amgen, the maker of Aranesp® and Epogen®, claims that a target hemoglobin range should be 11 to 12 grams per deciliter.

The dispute over proper ESA dosing began a month after the black box warning was added. Because the treatment of kidney patients is a major expense for Medicare, the addition of the warning prompted the program to decide that it would not pay for Epogen®, Procrit®, and Aranesp® in patients whose hemoglobin levels were at 10 grams per deciliter. That decision sparked controversy among physicians and members of Congress. As a result, Medicare has been waiting for the outcome of the FDA advisory panel meeting before enforcing its new dosing regulations.

Reference:

"Controversy over Aranesp, Epogen and Procrit to Be Addressed by FDA Panel," NewsInferno.com, September 2007.