The FDA has stated that amgen Inc must change the wording on the label of their anemia drug Aranesp.
According to the agency, the revised label must include risk factors that are present when the drug is given to cancer patients. These risks include dangerous side effects for cancer patients also receiving chemotherapy, and those with hemoglobin levels greater than, or equal to, 10 grams per deciliter should not receive it.
This move will not bode well for sales of Aranesp, which is already not selling as well as the company would like.
Studies have come out recently that show that the use of Aranesp to treat anemia in cancer patients can in fact make their cancer even worse.
The drug is also used by patients with kidney disease. It is estimated by leading analysts, that the label change will force another 40% reduction in sales.