FDA panel backs anemia drugs for kidney disease

— Federal health advisers said Monday that patients with failing kidneys should continue taking a group of widely used anemia drugs, despite a recent study showing they can increase the risk of stroke.




Doctors adjust their patients' drug doses to maintain healthy levels of hemoglobin, a component of blood that carries oxygen and keeps anemia patients active. Anemia causes weakness and shortness of breath and is a side effect of chemotherapy and kidney failure.

Current labeling on the drugs recommends keeping patients' hemoglobin levels between 10 grams and 12 grams per deciliter. The FDA asked its panelists whether the recommendation should be reduced to target 9 grams per deciliter. But a majority of panelists sided against that proposal in a vote of 9-5 with three abstentions. The experts said they worried patients would suffer more incidents of anemia and require more blood transfusions if lower doses were recommended. They said doctors should manage patients based on their individual health and disease history.

Panelists said additional studies are needed to find the ideal drug dosage for kidney disease patients.

"The label should be adjusted, but I just don't think we have enough information to recommend a fixed dose," said Dr. Judith Hochman of the New York University School of Medicine.

Amgen, based in California, makes all three drugs. Procrit is sold by Johnson & Johnson's Centocor Ortho Biotech division, under a long-standing agreement between the companies.


The Associated Press


