FDA panel affirms anemia drugs for predialysis use

Kidney patients who aren't on dialysis should still get their anemia-drug treatments, an FDA advisory panel says. After discussing new safety data on Amgen's high-tech anemia treatment Aranesp, the expert committee voted 15-1 against yanking the drug's indication for pre-dialysis treatment.

The panel's recommendation on whether the drug's dosage should be restricted wasn't quite as clear: Members voted 9-5 against cutting dosages of the drug, which are determined by patients' hemoglobin levels. FDA had asked whether to target hemoglobin levels of nine grams per deciliter, instead of the 10 to 12 grams now recommended. Rather than setting blanket rules, doctors should personalize dosing for each patient, panel members said. "One size fits all...does not apply here," said University of Texas medical professor Darren McGuire told Reuters. That doesn't mean that Aranesp--along with Amgen's Epogen and Johnson & Johnson's Procrit--are completely in the clear. Panel members did agree that the drugs present safety problems. But they said there's not enough data on the drugs' risks to warrant new restrictions. "I don't think we have enough evidence to make any changes right now," said panel member Henry Black of the New York University School of Medicine.

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- read the Dow Jones article

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