The drugs affected, known as erythropoiesis-stimulating agents or ESAs, are darbepoetin alfa (brand name Aranesp) and two epoetin alfa brands (Epogen and Procrit). All three brands are made by Amgen Inc of Thousand Oaks, California. Procrit is also marketed and distributed by Ortho Biotech LP, a subsidiary of Johnson and Johnson.
Contrary to the claims, these anemia-treatment drugs cannot increase energy or ease fatigue in patients undergoing cancer therapy, the FDA said. These drugs are genetically engineered versions of a natural protein, erythropoietin that increases the number of red blood cells - hemoglobin and is made in the kidneys.
The new product labeling covers updated warnings, boxed warnings and changes to dosing instructions. FDA also found that using excessive use of the drugs increased the risk of death, blood clots, strokes and heart attacks in patients with chronic kidney failure. In other studies, patients with head and neck cancer had more rapid tumor growth if they used higher-than-recommended doses.
However, Dr. Roger Perlmutter, Amgen's executive vice president of research and development told AP, "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."
A panel of FDA advisers is scheduled to discuss the drugs at a May 10 meeting following which further revisions would be carried out. All three drugs are approved by the FDA to treat patients whose anemia is caused by chronic kidney failure or chemotherapy treatment for cancer.
Anemia is the most common disorder of the blood. There are several kinds of anemia, produced by a variety of underlying causes. Reduced ability of the blood to transport essential oxygen to cells is called hypoxia which has varying degrees of severity.
