FDA Issues Dosing Guidelines for ESA Medications

Washington, DCThe US Food and Drug Administration (FDA) has issued new dosing guidelines for ESA (Erythropoiesis-Stimulating Agents) when the medications are used to treat anemia in patients who have chronic kidney disease. The new dosing guidelines come because FDA has information suggesting that Aranesp side effects and Procrit side effects, when used in patients with chronic kidney disease, could include an increased risk of cardiovascular events.

Erythropoiesis-Stimulating Agents are used to treat some forms of anemia that result from chronic kidney disease and chemotherapy. Included in the ESA class are Epogen, Procrit and Aranesp.

The FDA's new dosing recommendations are being added to the boxed warning of ESAs. The recommendations were made in response to trials that showed an increased risk of heart attack and stroke when ESAs are used to obtain normal blood hemoglobin levels. Specifically, the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT), showed that using ESAs to obtain a hemoglobin level higher than 11 g/dL increased the risk of serious cardiovascular events but provided no additional benefits.

Furthermore, FDA notes, there has not been an identified ESA dose that does not increase those cardiovascular risks. Changes to the label include removing the recommendation that ESAs be used to achieve and maintain hemoglobin levels of between 10 and 12 g/dL, and advising that ESA treatment begin when hemoglobin levels are below 10 g/dL.

Cardiovascular events associated with the use of ESAs include stroke, heart attack, heart failure and blood clots. Some of these events can be fatal.

Physicians are urged to monitor ESA doses in patients with chronic kidney disease and discuss the risks of cardiovascular events with their patients. They are further urged to weigh the benefits of using ESA medications versus the risk of cardiovascular adverse events when treating patients.

"The goal is to individualize therapy and use the lowest ESA dose possible to reduce the need for blood cell transfusions," John Jenkins, MD, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, said.

In addition to the recommendations, FDA has requested further clinical trials on ESA medications.