THE FDA WARNS DOCTORS TO USE CAUTION WITH CERTAIN ANEMIA DRUGS THAT ARE USED TO TREAT CHRONIC KIDNEY FAILURE ANEMIA AND FOR CHEMOTHERAPY EPOGEN PROCR

THE FDA WARNS DOCTORS TO USE CAUTION WITH CERTAIN ANEMIA DRUGS THAT ARE USED TO TREAT CHRONIC KIDNEY FAILURE ANEMIA AND FOR CHEMOTHERAPY EPOGEN PROCRIT and ARANESP

They have been hailed as genetic engineering wonder drugs and they do undoubtedly help many many people but storm clouds have been slowly growing around some of the anemia drugs. The anemia drugs Epogen, Procrit and Aranesp are the subject of an FDA warning.












Anemia means a decreased amount of red blood cells. People with anemia are weak and tired. There are different kinds of anemia and they get treated with different medications. For example,a very common form of anemia is iron deficiency anemia where blood loss happens from a slowly bleeding ulcer or in a woman with very heavy menstrual period For moderate iron deficiency anemia a doctor will prescribe iron supplements which help the body manufacture hemoglobin, which is the molecule that carries iron in the blood.



But for people with chronic kidney failure(renal failure) or who get chemotherapy the anemia may be something else. The kidney manufactures a hormone protein that stimulates the bone marrow to make red blood cells. The hormone is called erythropoetin. The process is called erythropoesis.



Epoetin is a man made form of the erythropoetin hormone protein that the body uses to make red blood cells. When people have chronic kidney problems they may not have enough functioning of this protein. Chronic kidney failure and cancer chemotherapy are both conditions where doctors prescribe these medications to raise the red blood cell count and treat anemia. Epogen, Procrit and Aranesp are approved to treat anemia in patients with chronic kidney failure and anemia caused by chemotherapy in certain patients with cancer. Epogen and Procrit are also approved for use in certain patients with anemia who are scheduled to undergo major surgery to reduce blood transfusions during or shortly after surgery and for the treatment of anemia caused by zidovudine (AZT) therapy in HIV patients.



The F.D.A has issued stronger warnings to doctors about the correct usage of the drugs intended to correct anemia from conditions like chronic renal failure(kidney) and chemotherapy. The FDA made the manufacturers put new boxed warnings emphasizing that erythropoeitin drugs caused tumor growth and shortened survival in some patients when they received a dose that attempted to achieve a hemoglobin level of 12 grams per deciliter (g/dL) or greater. For patients with chronic kidney failure, the new boxed warning states that eryhtropoetin drugs should be used to maintain a hemoglobin level between 10 g/dL to 12 g/dL. Maintaining higher hemoglobin levels in patients with chronic kidney failure increases the risk for death and for serious cardiovascular reactions such as stroke, heart attack or heart failure.

FDA Strengthens Boxed Warnings, Approves Other Safety Labeling Changes for Erythropoiesis-Stimulating Agents




"The new labels came after the F.D.A. held two advisory committee meetings to consider the safety of the drugs. The agency had first slapped a so-called black box warning, the toughest kind, on the drugs in March as an interim measure."For patients with kidney failure, the label calls for hemoglobin levels to be maintained at between 10 and 12. That is perhaps a bit less restrictive than the label in March. But new wording in the label calls for doctors to exercise restraint or possibly discontinue use for patients who do not reach the desired hemoglobin levels after 12 weeks of treatment".

Stronger Warnings on 3 Drugs for Anemia

F.D.A. Warning Is Issued on Anemia Drugs’ Overuse