US FDA asks for implementation of boxed warning for Erythropoiesis-Stimulating Agents (ESAs) products, will be approving modification in its Risk Evaluation and Mitigation Strategy for ESAs.
United States food and drugs recommends dosing guideline for Erythropoiesis-Stimulating Agents (ESAs) while treating chronic kidney disease patients, as it is found that Erythropoiesis-Stimulating Agents (ESAs) may increase the risks of getting cardiovascular events like thrombosis, strokes which become life threatening.
Hemoglobin is a vital constituent of human body and it is present in abundance in red blood cells, which carry oxygen from blood to all of our body tissues and organs maintaining normal functioning of our body, decreased in the level of hemoglobin results in to a condition known as anemia, which may be because of several diseases infections and conditions, which either cause impaired formation of hemoglobin or destruction of red blood cells as in malaria,
Kidney failure and anemia:
Kidney helps in filtering out toxic material out of our body in the form of urine and help in maintaining electrolyte balance in our body, in other term kidney filter out all bad toxins and unwanted metabolites in the form of urine. Therefore disturbed kidney function result in severe conditions like increased creatinine level and increased toxin levels in blood as well as the body electrolytes like calcium, potassium and phosphate levels are disturbed, resulting in to other severe events like cardiac arrhythmia, bone damage and water retention resulting in swelling and increased creatinine phosphate and calcium level resulting in muscular cramps ect.
Other function of our kidney is to produce a hormone known as erythropoietin which is responsible for stimulation of bone marrow cells responsible for production of red blood cells which is an important function in maintaining normal red blood cell count in normal individual, while in patients with impaired kidney function red blood cell count goes down causing anemic condition because of impaired production of erythropoietin.
Therefore patients with chronic kidney failure are normally treated with the erythropoiesis-Stimulating Agents which are nothing but the synthetic molecules similar to human erythropoietin the cytokine which regulates the production of RBC’S in bone marrow.
ESAs are synthetic versions of a human protein known as erythropoietin, which stimulates primitive cells in the bone marrow to produce red blood cells, the main oxygen-carrying cells in the blood. Blood hemoglobin is a laboratory measure of the number of red blood cells in the blood. Anemia is an abnormally low hemoglobin value.
It is found that Erythropoiesis-Stimulating Agents (ESAs) increase the risk of sever cardio vascular events there for US FDA has recommended to change the product label and inserts as until now which recommended dose of Erythropoiesis-Stimulating Agents (ESAs) for achieving and maintaining hemoglobin with in the range of 10 to 12mg/dl. Available Erythropoiesis-Stimulating Agents (ESAs)are epoetin alfa, brand names Epogen and Procrit, and darbepoetin alfa, brand name Aranesp.
Now the with the newly recommended label and inserts which will not give recommendation to targets for achieving and maintaining range for hemoglobin in CKD patients.
Therefore the Erythropoiesis-Stimulating Agents (ESAs) products labels and inserts will now bare a boxed warning for using Erythropoiesis-Stimulating Agents (ESAs) in CKD patients, which will help in making it an individualized therapy.