FDA Orders Amgen To Change Label Of Anemia Drug, Aranesp
July 31, 2008
Washington (dbTechno) - The U.S. Food and Drug Administration (FDA) has come out and ordered Amgen Inc. to change the label of their anemia drug, Aranesp.
The labels for this particular anemia drug, as well as other similar drugs are going to be changed to address many issues the FDA has with risks they pose to cancer patients.
The FDA has stated that the labels now need to state that the drugs are not meant for cancer patients who are going through chemotherapy.
Another addition to the label is that if a patient has hemoglobin levels greater than, or equal to, 10 grams per deciliter, they also should not take the drug.
Amgen has been fully ordered by the FDA to make all of the changes on their own.
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