Aranesp

darbepoetin alfa

Aranesp is an erythopoiesis-stimulating agents (ESA) prescribed for the treatment of anemia caused by kidney failure or chemotherapy treatment. ESAs, or anemia drugs, are genetically-produced forms of a naturally-occurring human protein known as erythropoietin. The kidney produces erythropoietin in the human body, which results in more red blood cells in the blood stream. Aranesp is administered by injection.

In clinical studies of patients with head and neck cancer who received higher than normal doses of Aranesp. it was found that patients experienced faster than normal growth of their cancer tumors. In clinical studies where patients were given recommended doses of Aranesp, in patients with cancer who were not undergoing chemotherapy, an increased risk of death was reported. In patients following orthopedic surgery there was an increase in blood clots when Aranesp was used at the recommended dose.

In response to these findings, the FDA issued a public health advisory on March 9, 2007 about newly revised safety labeling. A “black-box” warning was placed on all the ESAs, as well as updated risk warnings, and modified dosing instructions.

On September 24, 2007, the United States Medicare agency announced it will continue to refuse reimbursement for anemia drugs such as Aranesp because studies suggested the drug is linked to increased risks of stroke and heart attack.