Drug & Device News

The U.S. Food and Drug Administration (FDA) has altered the Boxed Warnings and other enclosed literature in the packaging of Erythropoiesis-Stimulating Agents (ESAs) to indicate that, for safety reasons, they should only be used when absolutely necessary. The agency has determined that when ESAs are used to treat anemia in patients with chronic kidney disease, those individuals are at increased risk of suffering adverse cardiovascular events, including stroke and thrombosis. The drugs Epogen and Procrit (epoetin alfa) and Aranesp (darbepoetin alfa), ESAs approved to treat anemia in patients with chronic kidney disease, were specifically identified in the June 24 FDA release describing the altered package warnings. In announcing the changes, John Jenkins, MD, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, 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 risk. The goal is to individualize therapy and use the lowest ESA dose possible to reduce the need for red blood cell transfusions.”