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Another Black Box Warning for Aranesp, Epogen, Procrit

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Aranesp, Epogen and Procrit, drugs used to treat anemia in patients undergoing chemotherapy, have been linked to shorter survival times, as well as increased tumor growth in some patients.   As a result, Aranesp, Epogen and Procrit will soon bear new black box warnings about these risks. The Food & Drug Administration (FDA) has also scheduled an advisory panel meeting for March to further discuss the safety issues surrounding Aranesp, Epogen and Procrit. At that meeting, the FDA could place more restrictions on the drugs, including a recommendation to lower the dose or that doctors stop prescribing the drugs for certain cancers.

A year ago, the FDA ordered a “black box” warning regarding cardiovascular problems and other safety issues posed by the drugs be included on their labels. Last 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. This past November, that black box warning was modified to include more specific dosing information.

The new black box warnings on Aranesp, Epogen and Procrit come on the heels of the PREPARE breast cancer study. That breast cancer study was one of 5 clinical trials that Amgen had agreed to after the safety of Aranesp was called into question. The new black box will cite information from PREPARE which showed patients had a higher risk of death on Aranesp. It also notes danger for patients with cervical cancer, based on results in December from a study called GOG-191.

The new warning for the anemia drugs is being added to precautions outlined in a black box at the top of prescribing information for the medicines. Amgen and Johnson & Johnson are also sending a letter to doctors informing them of the added warning.

Aranesp, Epogen and Procrit are known as erythropoiesis-stimulating agents (ESAs). All are made by Amgen, but Procrit is sold by Johnson & Johnson under a licensing agreement. ESAs are a bioengineered version of a natural protein made in the kidney that stimulates the bone marrow to produce more red blood cells. Approved uses of ESAs are for the treatment of anemia in patients with chronic kidney failure; for cancer patients whose anemia is caused by chemotherapy; and for those infected with the human immunodeficiency virus (HIV) whose anemia is caused by the HIV drug AZT (zidovudine). ESAs are also approved to reduce the number of transfusions during and after major surgery.

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