FDA: New Warning for Procrit, Epogen, Aranesp

June 27, 2011

BlankFDA: New Warning for Procrit, Epogen, Aranesp

Heart Attack, Stroke Risks Prompt Treatment Change for Chronic Kidney Disease

Patients

By J. DeNoon

WebMD Health News

Reviewed by J. , 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.

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.

" 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, " 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. "

Recommended Posts