Important Safety Advisory on Procrit, Aranesp, and Epogen

Posted on April 29, 2008

FDA has issued a Public Health Advisory which summarizes several recent safety concerns with the use of erythropoiesis stimulating agents (ESAs). These products, marketed as Procrit (epoetin alfa), Aranesp (darbepoetin alfa), and Epogen (epoetin alfa), stimulate the production of red blood cells. They are used to reduce the number of red blood cell transfusions given to patients with certain serious conditions who are, or may become, anemic.

FDA is re-evaluating the safe use of these products because a number of recent studies have shown an increased risk of serious and life-threatening side effects and a greater number of deaths in patients treated with ESAs. In one study of patients with chronic kidney failure there was an increased number of deaths and non-fatal heart attacks, strokes, heart failure, and blood clots when product dosages were adjusted to maintain hemoglobin levels higher than 12 g/dL.

In another study, patients with head and neck cancer receiving radiation therapy had a higher chance of death and faster tumor growth when ESA doses achieved hemoglobin levels higher than 12 g/dL.

Another study showed that cancer patients who were not on chemotherapy died sooner and did not require fewer blood transfusions when they were given these agents. And in yet another study, patients scheduled for orthopedic surgery who received ESAs to reduce perioperative blood transfusions had more blood clots than those not given an ESA.

The FDA Advisory contains a number of recommendations for prescribing these agents:

• Consider both the risks of transfusions and those of ESAs when deciding to prescribe these products.

• Adjust the dose of ESA to maintain the lowest hemoglobin level necessary to avoid the need for transfusions.

• Monitor patients' hemoglobin levels to ensure they don't exceed 12 g/dL.

In addition, prescribers should understand that there are no data to support claims that ESAs can improve quality of life for cancer patients whose anemia is caused by chemotherapy, or for HIV-positive patients whose anemia is caused by AZT. Also, these agents have not been shown to improve the outcomes of chemotherapy treatment.

The manufacturers of Procrit, Aranesp and Epogen have agreed to change the labeling for these products to reflect the new safety information and to provide additional instructions for their use.

Additional Information:

FDA MedWatch Safety Alert. Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), Procrit (epoetin alfa). March 12, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#ESA