FDA Issues Health Advisory on Procrit, Epogen, and Aranesp

Lee Coleman

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The FDA issued an advisory after a research study in The New England Journal of Medicine found a higher chance of patients treated with Procrit, an erythropoiesis- stimulating agent (ESA) also known as recombinant human erythropoietin, for a combination of hospitalizations, death, and heart attack, heart failure and stroke in those with chronic kidney disease who are not on dialysis. These patients were given Procrit to raise their hemoglobin higher than what the labeling for the product recommends. These products are used to increase blood hemoglobin levels, which is the oxygen carrying component of blood, by increasing the red blood cells in the body. They are also used to treat anemia in certain patients.

"In light of this research study, FDA is advising the following:
• To reduce serious complications from the use of ESAs, healthcare professionals should be familiar with the recommendations in the product labeling to maintain hemoglobin levels between 10 to 12 g/dL.
• Frequent tests to monitor blood hemoglobin levels are an important component of an ongoing ESA treatment plan. Healthcare professionals should talk with their patients about the importance of keeping appointments for simple blood tests to monitor hemoglobin levels.
• Patients should contact their doctor if they feel any worsening in shortness of breath, pain or the swelling in the legs or increases in blood pressure. "