The Food and Drug Administration (FDA) recommended lower dosage to check the cardiovascular events related to Erythropoiesis-Stimulating Agents (ESAs) which are used in anemia treatment for patients with chronic kidney diseases. Stroke, thrombosis and even death are the cardiovascular effects related to the dosing.
ESA’s are artificial erythropoietin which is a protein that stimulates the bone marrow cells to produce red blood cells which in turn carry oxygen in hemoglobin. The doctors measure this hemoglobin level in the blood so as to calculate the no. of erythrocytes or red blood cells in the blood. Anemic patients have a very low level of hemoglobin.
Epogen and Procrit (epoetin alfa), and Aranesp (darbepoetin alfa) are approved by FDA to treat anemia due to chronic kidney diseases. FDA examined different clinical trials that pointed towards increase in risk of cardiovascular events, especially when the treatment was aimed to achieve normal levels of hemoglobin in blood. Therefore the boxes will have the modified dosing guidelines.
The director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, John Jenkins, M.D. said “Health care practitioners should carefully consider when to begin treatment with an ESA and actively monitor dosing in patients with chronic kidney disease, keeping in mind the increased risk for serious cardiovascular events, and should talk to their patients about these potential risks. The goal is to individualize therapy and use the lowest ESA dose possible to reduce the need for red blood cell transfusions.”
The Centre for Disease Control and Prevention reports a whopping 20 million cases of chronic kidney diseases above the age of 20 throughout the US.
Experts say that ESAs should be considered to be given to the patients suffering from chronic kidney diseases who are not on dialysis only if the hemoglobin level falls below 10 g/dl. FDA recommends to stop the treatment as soon as the level rises above 10 g/dl. As for those who are on dialysis treatment, the dosage of ESAs should start when hemoglobin levels goes below 10 g/dl and should be stopped when it crosses the 11 g/dl mark.
The Executive vice president of Research and Development at Amgen, Roger M. Perlmutter, M.D., Ph.D. said “Amgen supports the modified ESA prescribing information as it informs physicians of important safety information. The revised label also provides physicians with more individualized treatment guidance by distinguishing between patients undergoing dialysis as compared with those who are not on dialysis.”