Patient Safety - Cardiovascular Risk

FDA is warning health care professionals that patients treated with erythropoietic agents may have an increased risk of cardiovascular complications if the dosing recommendations in the labeling are exceeded. These agents are used to stimulate the production of red blood cells in patients with severe anemia, and they are sold under the brand names Procrit, Epogen and Aranesp. FDA's advisory follows a recent study in the New England Journal of Medicine. In this study, anemic patients with chronic kidney disease were randomized to be dosed with Procrit to either a higher average target hemoglobin level (13.5 g/dL) or a lower level (11.3 g/dL). The patients being treated to the higher level experienced more cardiovascular complications than those being treated to the lower level. These complications included myocardial infarction, hospitalization for congestive heart failure, stroke and death. FDA also suggests talking to your patients about the importance of keeping appointments for simple blood tests to monitor hemoglobin levels. Advise them to call if they experience increased shortness of breath, pain, leg swelling or blood pressure while they're on the drug. FDA Patient Safety News: January 2007. Brought to you by SafetyTV Library, www.safetyissues.com. Life Has No Reset Button, Think Safety.