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FDA Requiring Label Changes for Amgen Anemia Drugs

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The Food & Drug Administration (FDA) has required tough new warnings and restrictions for Aranesp, Epogen and Procrit. Yesterday’s announcement that the agency was requiring further label changes and restrictions is the first time the FDA has used authority granted to it in 2007 to force a drug maker to change a drug’s label.

In March, an FDA advisory panel recommended new restrictions for the drug. The FDA mandated label will 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.

According to The New York Times, Amgen the maker of the drugs, 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.

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.

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.

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