FDA: New Warning for Procrit, Epogen, Aranesp

June 24, 2011 -- New data show that the way Procrit, Epogen, and Aranesp are used in patients with chronic kidney disease (CKD) may put them at risk of heart attack, stroke, and death, the FDA today warned.

More than 20 million Americans age 20 and older have CKD. All CKD patients taking these drugs should contact their doctors. Those taking the drugs for other conditions should be aware of the risk.

The drugs, all made by Amgen, are known as erythropoiesis-stimulating agents or ESAs. They signal the bone marrow to make more red blood cells and reduce anemia due to CKD or cancer chemotherapy.

Patients with CKD lose some of their ability to make new red blood cells and sometimes need blood transfusions. ESAs reduce the need for these transfusions.

Doctors test patients' hemoglobin levels to adjust ESA dosing. Currently, they have shot for a goal of 10 to 12 g/dL hemoglobin in patients with CKD.

But new evidence shows that patients who achieve this goal may have a significantly increased risk of heart attack, heart failure, stroke, and death.

Beginning immediately, the FDA says doctors and patients should abandon the concept of a target hemoglobin goal. Instead they should use only the smallest ESA dose needed to reduce transfusion frequency -- and should frequently test patients' blood to make sure hemoglobin levels don't get too high.

The advice is different for CKD patients on dialysis and for CKD patients not on dialysis.

For CKD patients on dialysis:

• Begin ESA treatment when the hemoglobin level is less than 10 g/dL.
• If the hemoglobin level approaches or reaches 11 g/dL, reduce the ESA dose or suspend treatment.

For CKD patients not on dialysis:

• Consider ESA treatment only when the hemoglobin level is less than 10 g/dL, and the rate of hemoglobin level decline suggests need for a blood transfusion is likely, and a goal of treatment is to reduce the risk of immunization against non-self factors in transfused blood and/or reducing transfusion risks.
• If the hemoglobin level goes over 10 g/dL, reduce the ESA dose or suspend treatment.

"We now recommend that doctors and patients should weigh the possible benefits of ESAs to decrease the need for red-blood-cell transfusion against increased risk of serious cardiovascular events," Robert C. Kane, MD, FDA acting deputy director for safety of hematology products, said at a news teleconference. "For each patient, doctors should individualize dosing and use only the dose sufficient to reduce the need for transfusions."