From Our 2011 Archives
FDA: New Warning for Procrit, Epogen, Aranesp
Heart Attack, Stroke Risks Prompt Treatment Change for Chronic Kidney Disease Patients
By Daniel J. DeNoon
Reviewed by Laura J. Martin, MD
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.
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:
For CKD patients not on dialysis:
"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."
SOURCES: News releases, FDA.FDA news teleconference, June 24, 2011.Robert C. Kane, MD, acting deputy director for safety of hematology products, FDA. ©2011 WebMD, LLC. All Rights Reserved.