FDA demands new labels for Amgen anemia drugs

The FDA has demanded that drugmaker Amgen change the labels for its top-selling anemia drugs in a way that could further limit their use in treating cancer patients. In making the order, the FDA made its first use of a 2007 law allowing it to require changes in prescribing information. The drugs, Aranesp and Procrit, have already seen dramatic decreases in sales since studies suggested that using them to treat chemotherapy-related anemia could worsen cancer or hasten death.

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.

The bad news coming out of the previous studies had already cut sales of Aranesp 13 percent to $825 million. Now, experts say, things should get worse for Amgen. One analyst, Yaron Werber of Citi Investment Research, estimated that the new label could cut the use of Aranesp for cancer patients in this country by 40 percent, cutting annual sales by $264 million.

To learn more about this change:
- read this piece in The New York Times

Related Articles:
Amgen stock slips as anemia drug concerns rise
FDA wants more data on new Aranesp doses
New study points to danger of anemia drug

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