FDA changes recommended dose o

On June 24, the United States food and Drug Administration (FDA) announcement says, when the red blood cell stimulating factor (ESAs) for the treatment of chronic kidney disease (CKD) patients when anemia, due to increased cardiovascular events (such as stroke, thrombosis and death) of the dangerous, the recommended dosage of the more conservative guidelines.ESAs is a synthetic human proteins, called erythropoietin, their original human red blood cells in bone marrow.ESAs has been approved for the treatment of CKD, chemotherapy, and other diseases caused by some types of anemia. ESA drugs including Australopithecus afarensis Epoetin Epsilon (Epoetin Alfa, trade names: Epogen and Procrit) and afadabei parking Ting (darbepoetinalfa, trade name: Aranesp).the modified recommendation be added to a black box warning on the box and the rest of the manual, because clinical trials have shown, when doses of ESAs used so that when the hemoglobin concentration in patients with normal or near normal, cardiovascular events (such as heart attacks and stroke) at increased risk. In addition, ESAs not appearing can improve patients ' quality of life, fatigue or health conditions.United States Director of the FDA Center for drug evaluation and Research Office of the new drug John · Jenkin (Slovakia) said “ medical personnel in the when started to use ESAs in patients with chronic kidney disease treatment, care should be taken into account, and to actively monitor the dose, the drug increases the risk of serious cardiovascular events in mind, and should inform their patients of the potential danger. &Rdquo;“ the goal is to give individualized treatment, with a minimum dose of ESA reduce the need for red blood cell transfusion in patients with ”.under United States Centers for disease control and prevention statistics, United States with more than 20 million cases of &GE;20 aged CKD patients. Prior to this, use doses of ESAs product label has been recommended for the CKD patient's haemoglobin levels up to and maintained at 10-12 g/dl. Modify the instructions to remove this “ target hemoglobin range ” concept.modifications, ESA recommended in the product package insert as: physicians and their patients with chronic kidney disease, should be weighed using ESAs may benefit in reducing red blood cell transfusion demand, and increases the risk of serious adverse cardiovascular events. Each patient, individualized dose of programmes and adequate to reduce transfusion needs minimal doses of ESA.for anemia in chronic kidney disease patients without dialysis:&Bull;  <10 g/dl only when the haemoglobin levels, and when certain other considerations before considering starting ESA therapy. &Bull;  If the haemoglobin level more than 10 g/dl to reduce ESA dose or discontinuing treatment.for dialysis patients with anemia of chronic kidney disease:&Bull;  when the haemoglobin level <10 g/dl start ESA therapy. &Bull;  If hemoglobin levels when you approach or exceed 11 g/dl, reduce ESA dose or discontinuing treatment.give ESA the first agent at the beginning, this circular does not define when patients when hemoglobin levels lower than 10 g/dl how much, start the ESA is appropriate. The circular did not recommend the treatment goal is to make hemoglobin reached 10 g/dl or above. Individualized dose for each patient should be given to programmes.chronic patients with CKD, ESA dose modification recommendations based on information on clinical trials, including TREAT test (test treatment with Aranesp reduce cardiovascular events), the test displays, use ESAs achieve the goal of >11 g/dl hemoglobin level, increased severe cardiovascular adverse events (such as heart attacks and stroke) of the dangerous, and the patient has no additional benefit.FDA said, will continue to evaluate the security of ESAs, and requiring producers to additional clinical trials.original link: FDA modifies dosing recommendations for Erythropoiesis-Stimulating Agents www.CMT.com.C