FDA demands new labels for Amgen anemia drugs

August 4, 2008

The Food and Drug Administration has ordered Amgen to change the labels for its flagship anemia drugs in a way that could further restrict their use in treating patients with cancer.

The move, which the F.D.A. announced on Wednesday, represents the first time the agency has invoked authority under a 2007 law that empowered it to order changes in a drug’s prescribing information. Previously, the F.D.A. could only negotiate with a drug’s manufacturer to change the label.

Sales of the drugs, Aranesp and Procrit, have already plummeted in the last year because of studies suggesting that their use to treat the anemia caused by chemotherapy could actually make cancer worse or shorten lives. Procrit is manufactured by Amgen but sold under license by Johnson & Johnson.

The new labels will say that treatment with these drugs shouldn’t begin until a patient’s hemoglobin drops to 10 grams per deciliter of blood. Meanwhile, language that might imply that it was safe to continue treating patients until their hemoglobin rose to 12 grams per deciliter has now been removed. The newly-updated labels will also say that the drugs shouldn’t be used if chemotherapy is being used to cure patients, rather than extend life.

read this piece in The New York Times