The Food and Drug Administration has approved new warnings to be printed on a type of drugs that includes Aranesp and Epogen, two popular anemia products developed by the Thousand Oaks drug maker Amgen Inc. The revised warnings indicate that erythropoiesis-stimulating agents increase the risk of death and “serious cardiovascular events” when given to patients with cancer and kidney disease. It also notes “patients should be informed of the increased risks of mortality, serious cardiovascular events, thromboembolic events, and tumor progression when used in off-label dose regimens or populations.” The new warnings are in response to mounting concern that NSAs such as Aranesp and Epogen are dangerous to some patients. The FDA approved Aranesp to treat anemia in patients with kidney diseases and anemia induced by chemotherapy, however recent clinical trials of the drug among cancer patients not undergoing chemotherapy have show negative results. In one instance, the drug was found to cause a higher risk of death. The FDA is planning to review ESAs in May, but already there has been fall-out. Earlier this week, Noridian Administrative Services LLC, which administers Medicare in several Western states, said it would no longer pay for Aranesp for use by cancer patients. The company cited safety concerns. Amgen officials have always held that Aranesp is safe, but concede to the new warnings. “Patient safety is unquestionably our top priority. Amgen is committed to providing timely and appropriate communications to physicians and patients whenever we become aware of new safety information that could affect clinical practice,” said Dr. Roger M. Perlmutter, executive vice president of research and development at Amgen, in a prepared statement released Friday.
