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Aranesp, Epogen, Procrit Label Updated Over Safety Concerns

Nov 8, 2007 | Parker Waichman LLP

The labels of Aranesp, Epogen and Procrit, drugs used to treat anemia, are being updated to include new dosage guidelines and specific information on the drugs’ cardiovascular side effects.   The label modifications come less than a year after the Food & Drug Administration (FDA) ordered a “black box” warning regarding cardiovascular problems and other safety issues posed by the drugs be included on their labels.  All three medications are manufactured by Amgen, although Procrit is sold by Johnson & Johnson under a licensing agreement.  

Aranesp, Epogen and Procrit are all part of a class of drugs known as erythropoiesis-stimulating agents (ESAs).  ESAs treat anemia in patients with kidney disease or certain cancers by boosting red blood cells.  However, several studies have linked the anemia drugs to cardiovascular problems and deaths.  They have also been tied to worsening tumors when used in cancer patients.  Soon after Epogen was introduced, some doctors attempted to use it to increase patients’ hemoglobin (the part of the blood cell that carries oxygen) to levels as high as14 grams.   A healthy person would normally have a hemoglobin level between 13.5 and 14.  Two clinical trials showed that the large dosage required to attain such high hemoglobin levels could lead to heart problems and death.  In March, the FDA added a black box warning to the drugs’ labels cautioning doctors that the medications should be administered at the lowest dose possible in order to bring red blood cell counts to the lowest level necessary to avoid transfusions.  The warning labels said hemoglobin levels should not be allowed to go above 12 grams per deciliter of blood.   

The modified black box warning on Aranesp, Epogen and Procrit now has more specific dosing information.  It now states that dosing should be individualized to "achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL."   For kidney patients, the new warning now reads that “patients experienced greater risks for death and serious cardiovascular events when administered ESAs to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies' rather than the more generic warning that risks were seen when hemoglobin levels of greater than 12 were target.

Amgen also announced that it planned to ask the Centers for Medicare and Medicaid Services to loosen payment restrictions for Aranesp, Epogen and Procrit.  Shortly after the FDA added the black box warning in March, Medicare announced that program would not pay for Aranesp, Epogen and Procrit in patients whose hemoglobin levels were at 10 grams per deciliter.

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