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Procrit, Aranesp, Epogen Could be Restricted by FDA

Mar 12, 2008 | Parker Waichman Alonso LLP

Procrit, Aranesp and Epogen, anemia drugs used to treat chemotherapy patients, could soon have new restrictions imposed on them by the Food and Drug Administration (FDA).  Late last week, the FDA announced a new black box warning for Procrit, Aranesp and Epogen regarding their association with shortened survival and increased tumor growth in some cancer patients.  Now there is speculation that the FDA is getting ready to rescind it approval of Procrit, Aranesp and Procrit to treat anemia in cancer patients.

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.

The latest black box to be included on the labeling of Procrit, Aranesp and Epogen came 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.

That warning followed the addition of two other black box warnings for the drugs.  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 also 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.

Tomorrow, the FDA's cancer-drugs advisory committee will recommend what action the regulator should take.   According to The Wall Street Journal, the FDA will ask the advisory panel to consider several restrictions on Procrit, Aranesp and Epogen beyond the black box warnings.  According to documents made public by the FDA yesterday, this could include eliminating their approval for cancer patients.    If that happened, the drugs would remain on the market for other uses, particularly in kidney failure.  And doctors could still choose to prescribe Procrit, Aranesp and Epogen for cancer patients as an off-label use, as physicians are free to use approved drugs in any way they see fit.

Other restrictions the FDA could impose on Procrit, Aranesp and Epogen include requiring cancer patients to sign informed consents before they take the medicines, confining distribution of the drugs, or asking the drugs' makers to voluntarily limit their advertising and promotion.  The FDA is also asking advisors to weigh targeted limits, such as recommending the drugs' use only in small-cell-lung-cancer patients.