Monday, August 04, 2008

Anemia Drugs Label Change

The FDA has ordered label changes on cancer patients' use of drugs with erythropoiesis- stimulating agents (ESA) made by the companies. The changes would be added to a "Black Box" warning. The drugs are Epogen and Aranesp.

The FDA states that the new label must stated that the drugs are not to be used in cancer patients receiving chemotherapy when a cure of the cancer is anticipated.

As part of the label change, there will be a statement added that the drugs should not be administered when hemoglobin levels are greater to or equal to 10 grams per deciliter and that usage should stop if the hemoglobin exceeds a level needed to avoid transfusion.

Link here.