Procrit®,Epogen®,and Aranesp®,Linked to Deadly Side Effects.

Three common drugs usedto treat anemia, Procrit® (Epoetin alfa), Aranesp® (Darbepoetin alfa), and Epogen® (Epoetin alfa), have been linked to serious complications in cancer and kidney patients. The drugs, erythropoiesis stimulating agents (ESAs), are approved to treat anemia inpatients with chronic kidney failure and in patients with cancer whose anemia is caused by chemotherapy. Epogen and Procrit are used for patients scheduled for major surgery to reduce potential blood transfusions and for the treatment of anemia in HIV patients.

The manufacturers of Aranesp, Epogen, and Procrit, have been asked by Congress to stop advertising their popular anemia drugs to consumers. On March 21, 2007 letters were sent to Amgen, which markets Aranesp and Epogen, and Johnson & Johnson, which makes Procrit, requesting them to stop advertising their potentially life-threatening products until the FDA further assesses the safety of these common and over-prescribed anemia drugs.

The letters have requested that both companies detail to Congress exactly how they market their anemia drugs andif there are any financial incentives (kickbacks) paid to physicians to prescribe them.

The three products combined had U.S. sales of $10 billionin 2006. From those sales, $700 million in annual sales ofthe drugs are estimated to come from “off label” uses, i.e.not FDA approved.

On March 9, 2007 the FDA announced new “black box” warning labels for the drugs, citing an increased risk of blood clots, heart attacks and even death in kidneypatients when the drugs are taken at higher than recommended doses. Patients with head and neck cancers developed tumor growth faster when given the higher doses.

In studies where ESAs were given at recommended doses, an increased risk of death was reported in patients with cancer who were not receiving chemotherapy and an increased risk of blood clots was observed in patients following orthopedicsurgery. These studies have shown that when physicians use the hormone-like drugs to “cure” the anemia commonly seen in cancer and kidney-failure patients, some patients suffer complications and die earlier.