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FDA Advisers Back Anemia Drugs for Kidney Patients
Date:10/19/2010

risks with the patients and obtain signatures authorizing their use.

The FDA also requires certification and active, continuing enrollment in an educational program for all doctors prescribing ESAs to cancer patients.

The rules do not apply to people given ESAs for conditions other than cancer.

The decision to treat someone with chronic kidney disease with an ESA must be made patient-by-patient, Singh said. But one major factor is whether the patient requires dialysis, he said.

"Those who are on dialysis tend to have severe anemia," Singh said. "Those who are not on dialysis usually have anemia that is less severe."

Dr. Jeffrey S. Berns, professor of medicine and pediatrics at the University of Pennsylvania, agreed that use of an ESA must be decided case by case. But to him, the overall condition of a patient is more important in making the decision than whether the patient is on dialysis.

"To go to the extremes, if you have a 95-year-old in a wheelchair, I see no reason to treat," Berns told HealthDay last spring. "If you have a 32-year-old who is active and wants to remain so, I see no problem in using an ESA to get the hemoglobin up."

One reason why the meta-analysis found so many problems, Berns said, is that studies tend to have few young people in them. "It may be the much older patient populations that were studied," he said. "No matter what you did to them, you may not be able to show much improvement in quality of life."

More information

The U.S. Food and Drug Administration has more on ESAs.

-- HealthDay staff

SOURCES: Ajay K. Singh, M.D., associate professor, medicine, Harvard Medical School, and director, renal division and dialysis services, Brigham and Women's Hospital, Boston;
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