FDA to convene panel to discuss anemia drug.Safety questions surrounding anti-anemia drugs by Amgen and Johnson & Johnson (J&J) will be addressed by an FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. panel in September, "The Wall Street Journal" reported. In a Federal Register notice published July 20, FDA said that it would convene a joint meeting of its cardiovascular and renal drugs advisory committee and the drug safety and risk management advisory committee Sept. 11, to discuss "updated information on the risks and benefits" of Aranesp, Epogen and Procrit when used in the treatment of anemia in patients with kidney failure kidney failure or renal failure Partial or complete loss of kidney function. Acute failure causes reduced urine output and blood chemical imbalance, including uremia. Most patients recover within six weeks. . Aranesp and Procrit are approved to treat anemia associated with chemotherapy. Aranesp and another Amgen drug, Epogen, also are approved to treat anemia in people with kidney disease Kidney Disease Definition Kidney disease is a general term for any damage that reduces the functioning of the kidney. Kidney disease is also called renal disease. . Procrit and Epogen are identical except for the product label; J&J markets Procrit under a license agreement with Amgen. FDA is concerned the drugs could promote tumor tumor: see neoplasm. progression in some patients, as well as cut down on overall survival. Most of the studies showing such problems involve the drugs being used at higher-than-recommended doses. The products fall into a class of drugs known as erythropoiesis-stimulating agents. The drugs treat anemia by boosting the number of red blood cells Red blood cells Cells that carry hemoglobin (the molecule that transports oxygen) and help remove wastes from tissues throughout the body. Mentioned in: Bone Marrow Transplantation red blood cells . Until recently, they had been commonly used off-label to treat fatigue in cancer patients and in cancer patients not receiving chemotherapy. In May, another FDA panel said the drugs should face additional restrictions on their product labels; soon after, Medicare proposed limiting payments for the drugs. FDA officials then said they wanted to convene the cardiovascular and renal drugs panel to discuss the drugs before making additional regulatory decisions. In March, FDA added the agency's toughest "black box" warning, which discusses a variety of safety concerns to Aranesp, Amgen's top selling-drug, as well as to Epogen and Procrit. The boxed warning also recommends the drugs be used at the lowest dose possible to boost red blood cell red blood cell: see blood. levels to the lowest level necessary to avoid blood transfusions blood transfusion, transfer of blood from one person to another, or from one animal to another of the same species. Transfusions are performed to replace a substantial loss of blood and as supportive treatment in certain diseases and blood disorders. . |
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