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FDA Forces New Labeling for Procrit, Aranesp and Epogen

Jul 31, 2008 | Parker Waichman LLP

Federal regulators have decided that the anemia drugs Aranesp, Epogen and Procrit need to have additional safety-related changes to their labels.  The changes mandated by  the Food & Drug Administration (FDA)  would restrict the use of the drugs in some cancer patients.

Procrit, Aranesp and Epogen are known as erythropoiesis-stimulating agent (ESA).  All are made by Amgen, but Procrit is sold by Johnson & Johnson subsidiary Ortho Biotech 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. When Procrit was first approved in 1989, the drug was touted as a treatment to lessen fatigue and improve quality of life among cancer and HIV patients with anemia. But since then Procrit has been forced to undergo five label changes, and the label now states that there was no evidence to back that claim.

This past March, Amgen and Johnson & Johnson announced that they would be including another black box warning on the drug’s labels.  The black box warned of the medications’ association with increased tumor growth and shortened survival time in some cancer patients.  The warning 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.  PREPARE showed patients had a higher risk of death on Aranesp.  The warning also noted danger for patients with cervical cancer, based on results in December from a study called GOG-191.

That same month, an FDA advisory panel recommended new limits be placed on the drugs.  Yesterday's announcement that the agency was requiring further label changes and restrictions is the first time FDA using authority granted to it in 2007 to force a drug maker to change a drug's label.   Apparently, the FDA and Amgen were not able to reach agreement over the label changes.  According to The New York Times, Amgen had wanted the label to give doctors discretion to initiate therapy before hemoglobin levels dropped to 10 in patients who could not tolerate that degree of anemia. And it wanted mention of the 12 gram upper limit for stopping therapy.

The new label will say that say that the drugs shouldn't be used in cancer patients receiving chemotherapy when a cure of their cancer is anticipated.  The FDA also ordered inclusion of a statement that the drugs aren't to be administered when hemoglobin levels are greater than or equal to 10 grams per deciliter. Language is being removed that seemed to imply that it was safe to continue treating patients until their hemoglobin rose to 12 grams per deciliter.

Despite the FDA's tough stance regarding the anemia drug's, the new labeling does not incorporate all of the recommendations the advisory panel made in March.  The panel had also advised that patients with advanced breast cancer and head-and-neck cancer shouldn't get the medicines.


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