FDA tells Amgen to change anemia drug labels

8/1/2008

WASHINGTON Amgen has been told by the Food and Drug Administration to change the label for its anemia drugs Procrit and Aranesp in order to restrict the drug’s use in cancer patients, according to published reports. This represents the first time the agency is using the authority that was presented to it as a result of the FDA Amendments Act of 2007. Prior to this, the FDA could only negotiate with a company to change its labels.

The new labels will say that treatment with the drugs should not begin until a patient’s hemoglobin drops to 10 grams per deciliter of blood. Also, 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. The FDA also ordered the new labels to say that the drugs shouldn’t be used in cancer patients receiving chemotherapy. However, the new labels will not advise against use of the drugs for all patients with breast cancer or head and neck cancer.

Both Amgen and Johnson & Johnson, who sells Procrit under a deal with Amgen said they would both cooperate with the FDA. Amgen also announced that it was aware with the changes the FDA was going to make and anticipated it in its second quarter results which were released at the beginning of the week. Both drugs dropped in sales in the United States and worldwide during the second quarter. Aranesp alone fell 26 percent in the United States during the second quarter to $427 million. Procrit and a similar drug, Eprex, dropped 14 percent worldwide in the second quarter, to $652 million, and fell 23 percent in the United States to $346 million

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