Anemia Drugs Pose Health Risk

Christina Cole

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On Friday, the FDA issued a public health advisory to warn patients and care providers that the use of common anemia drugs can increase a risk of death and other serious problems in kidney disease or cancer.

The drugs that are causing concern are Epogen, Aranesp and Procrit, all of which are erythropoiesis-stimulating agents. Genetically engineered, these drugs are versions of a natural protein known as erythropoietin that increases red blood cells.

Recent studies and research show these drugs in higher doses indicate an increased risk of death, blood clots, heart attack and stroke in patients with chronic kidney failure. High doses of these agents promoted tumor growth in the patients that have head and neck cancer.

The FDA wants new boxed warnings to advise doctors to monitor red blood cell counts and to adjust the ESA dose to help maintain the lowest hemoglobin levels need to avoid any need for a blood transfusion.

The safety concerns resulted from earlier ESA studies discussed during a 2004 meeting of the Oncologic Drugs Advisory Committee. Product labeling was previously revised in 1997, 2004, and 2005 to reflect new safety information.

The drugs, Aranesp, Epogen, and Procrit, are approved to treat anemia in patients with chronic kidney failure and in patients with cancer whose anemia is caused by chemotherapy.

Epogen and Procrit are indicated for patients scheduled for major surgery to reduce potential blood transfusions and for the treatment of anemia due to zidovudine therapy in HIV patients.