FDA may have new restrictions on Procrit, Aranesp and Epogen

Procrit, Aranesp and Epogen

An article released by the associated press yesterday reported the FDA may have new restrictions on Procrit, Aranesp and Epogen. These drugs appear to double the risk for stroke in patients with kidney disease.

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On Thursday the FDA posted a safety review on these medications from Amgen Inc. The restrictions are focusing on the use in patients with chronic kidney disease who are not yet receiving dialysis.

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Quoted from the article

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"The medicines — Procrit, Aranesp and Epogen — are multibillion dollar sellers because of their ability to boost oxygen-carrying red blood cells, reducing the need for painful blood transfusions. But sales have fallen sharply since 2007, when the FDA added the first of several safety warnings to the drugs, based on evidence they can cause tumor growth and hasten death in cancer patients. The drugs are no longer used in patients with several types of cancers".

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Next Monday the FDA will consult with an outside panel of experts and go over the data asking for their recommendations on warning labels, additional studies or lower doses of the drugs.

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In the treatment of Hepatitis C Procrit and Epogen are often used as rescue drugs, on the Procrit website they have this warning which was revised in 2009:

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Cases of pure red cell aplasia (PRCA) and of severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin have been reported in patients with chronic renal failure receiving PROCRIT® by subcutaneous administration. PRCA has also been reported in patients receiving ESAs while undergoing treatment for hepatitis C with interferon and ribavirin. If any patient develops a sudden loss of response to PROCRIT®, accompanied by severe anemia and low reticulocyte count, and anti-erythropoietin antibody-associated anemia is suspected, withhold PROCRIT® and other erythropoietic proteins.

Contact Centocor Ortho Biotech (1-800-457-6399) to perform assays for binding and neutralizing antibodies. If erythropoietin antibody-mediated anemia is confirmed, PROCRIT® should be permanently discontinued and patients should not be switched to other erythropoietic proteins

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From September 30th Also See :

Recall/Anemia drugs Procrit and Epogen

List Of Lot # / Recalls Epogen and Procrit

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