The trial was examining patients who had cancer but were not receiving chemotherapy or radiation.
The trial was designed to see whether Aranesp would be useful for patients with anemia caused by their cancer. Aranesp is already approved to treat anemia caused by cancer chemotherapy but not by the cancer itself.
Patients with anemia often need blood transfusions to restore their levels of hemoglobin. The trial showed no statistically significant difference in the frequency of blood transfusions in the population receiving placebo injections as opposed to those receiving Aranesp.
Amgen said that there was a statistically significant increased risk of death in the Aranesp-treated group.
Amgen did not provide a detailed assessment of the trial but concluded that, for these patients who are not receiving chemotherapy, “The risk/benefit ratio for Aranesp use is at best neutral and perhaps negative.”
It is thought that the report will raise questions about the side effects of similar drugs on the market. This announcement by Amgen follows a recent report suggesting that Johnson & Johnson’s Procrit induces side effects, including heart attacks, when used aggressively. Recent speculation has focused on concerns about the overuse of these types of drugs.
A review is now underway at the US National Kidney Foundation to assess whether a change is needed in how these drugs are administered.