Cardiovascular Risk with Erythropoietic Agents (Jan. 2007)

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.

The labeling for Procrit, Epogen and Aranesp already recommends treating patients to achieve blood hemoglobin levels no higher than 12 g/dL. To reduce the risk of serious complications with these drugs, FDA's advisory says to be sure to follow the labeling recommendations, and maintain a hemoglobin range between 10 and 12 g/dL.

In addition, after adjusting the dose of one of these agents, FDA recommends measuring the patient's hemoglobin twice a week for 2 to 6 weeks to ensure that hemoglobin levels have stabilized. Decrease the dose if the hemoglobin increase exceeds 1g/dL in any 2 week period.

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.

Additional Information:

FDA MedWatch Safety Alert. Erythropoiesis Stimulating AgentsProcrit, Epogen, and Aranesp. November 17, 2006
http://www.fda.gov/medwatch/safety/2006/safety06.htm#erythropoiesis

Category:

News & Politics

Tags:

• Cardiovascular
• Risk
• Erythropoietic
• Agents
• FDA
• Anemia
• Procrit
• Epogen
• Aranesp
• Kidney
• Disease
• Drug
• Reaction
• Patient
• Safety

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