FDA Tightens Warnings on Anemia Drugs

Higher-than-recommended doses can be fatal to kidney, cancer patients

By Steven Reinberg
HealthDay Reporter

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FRIDAY, March 9 (HealthDay News) -- U.S. health officials issued new warnings Friday for the popular drugs Aranesp, Epogen and Procrit, prescribed to treat anemia, saying they can increase the risk of death and other serious health problems in patients with kidney disease and cancer.

Recent studies showed that the drugs -- called erythropoiesis-stimulating agents (ESAs) -- can lead to blood clots, strokes, heart attacks and death in patients with chronic kidney failure who received them at higher-than-recommended doses. Other studies found that the higher doses can produce more rapid tumor growth in patients with head and neck cancer, the U.S. Food and Drug Administration said.

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The drugs included in the new safety update are darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit). These drugs are genetically engineered versions of a natural protein, erythropoietin, that increases the number of red blood cells to combat anemia. Anemia is a common side effect with certain forms of kidney disease, especially for patients undergoing dialysis, and for cancer patients undergoing chemotherapy.

The three drugs 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 approved for patients scheduled for major surgery to reduce potential blood transfusions and for the treatment of anemia due to zidovudine therapy in HIV patients, the FDA said.

"The new warning tells physicians to monitor red blood cell levels and to adjust the dose of these drugs to maintain the lowest red cell level needed to avoid blood transfusions," Dr. Richard Pazdur, director of FDA's Office of Oncology Drug Products, said during a teleconference.

The new boxed warning will note that when these drugs are given with a red blood cell count greater than 12 grams per deciliter, they can increase the risk for death, blood clots, and serious cardiovascular events.

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