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Aranesp, Epogen, Procrit Get Another Black Box Warning

Mar 10, 2008 | Parker Waichman Alonso LLP

Aranesp, Epogen and Procrit, drugs used to treat anemia in patients undergoing chemotherapy, will soon bear new black box warnings that they may shorten survival time in patients with certain types of tumors.  Amgen's Aranesp and Epogen, and Johnson & Johnson's Procrit, have been under scrutiny for some time after several studies showed some patients treated with the drugs die sooner than others.  In addition to the warning on survival time, the new black box warning for Aranesp, Epogen and Procrit will also say that tumors may spread more quickly in patients on the drugs.

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.

A year ago, 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. 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.

The FDA has 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.