Tampa, Fla., March 13, 2007.- Today the American Association of Kidney Patients (AAKP) issued a response to the recent Food and Drug Administration’s (FDA) warning advising prescribing changes for the use of erythropoiesis stimulating agents (ESAs). ⁽¹⁾The FDA warning cited several popular drugs used to treat anemia (Aranesp, Epogen, and Procrit), and their ability/likelihood to increase the risk of death and other serious health problems in patients with kidney disease.

According to members of the AAKP Medical Advisory Board, this warning may be confusing to patients as well as to providers. AAKP’s statement urges patients to discuss their anemia management with their physicians.

• The history of ESAs dates to 1989 ⁽²⁾⁽³⁾. Since their introduction, the hospitalization rate, blood transfusion rate and blood borne illness rate have dropped. In addition, ESRD mortality rates and quality of life for all CKD patients have improved.
• Although originally designed and approved by the FDA as a measure to avoid blood transfusions, the clinical practice patterns since 1989 have evolved such that current standard of care, is to use ESAs to achieve a hemoglobin greater than 11 to get the best health benefits for CKD patients.
• If the renal community were to revert to dosing ESA just to avoid blood transfusions, the hemoglobin levels would likely be lower than 11, and there are serious concerns that the quality of life and productivity of many patients will suffer.
• The management of anemia should be determined by the patient’s needs and the decision-making shared with the physician. It should be based on the results of recent clinical trials ⁽⁴⁾⁽⁵⁾.
• The AAKP Medical Advisory Board agrees with current practice standards and evidence and supports targeting the hemoglobin between 11 and 12 to achieve a hemoglobin of at least 11.
• Temporary increases of hemoglobin to greater than 12 are common because of the variability in patient responses and have not been proven to be harmful. These temporary increases are usually well tolerated and easily treated by decreasing the ESA dose.

“ESAs have helped complete the miracle of dialysis for thousands of patients, and should be allowed to continue contributing to their quality of life and productivity” says AAKP Vice President Stephen Fadem, M.D., FASN. “AAKP’s priority is to put patient safety first. While we want to make sure patients and physicians understand what the FDA means by issuing the black box warning, we do not want a patient to panic, suddenly stop taking his or her medication or a physician to stop appropriately prescribing these drugs. Problems with ESA use only occurred in CKD when unapproved regimens were used.”

According to the FDA, recently completed studies describe an increased risk of death, blood clots, strokes, and heart attacks in patients with chronic kidney failure when ESAs were given at higher than recommended doses. FDA and the manufacturer of the anemia treatment products have agreed on revised product labeling that includes updated warnings, a new boxed warning, and modifications to the dosing instructions.

For more information on the FDA black box warning, call the AAKP National Office at (800) 749-AAKP. You can also get more information by logging onto the AAKP Web site, www.aakp.org.

# # #

References

1.          FDA Strengthens Safety Information for Erythropoiesis-Stimulating Agents (ESAs).  2007  [cited; Available from: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01582.html.

2.         Eschbach, J.W., et al., Treatment of the anemia of progressive renal failure with recombinant human erythropoietin. N Engl J Med, 1989. 321(3): p. 158-163.

3.         Eschbach, J.W., et al., Recombinant human erythropoietin in anemic patients with end-stage renal disease. Results of a phase III multicenter clinical trial. Ann Intern Med, 1989. 111(12): p. 992-991000.

4.         Singh, A.K., et al., Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med, 2006. 355(20): p. 2085-2098.

5.         Drueke, T.B., et al., Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med, 2006. 355(20): p. 2071-2084.