FDA Advisers Back Anemia Drugs for Kidne... ( TUESDAY Oct. 19 (Heal...)

FDA Advisers Back Anemia Drugs for Kidney Patients

Date:10/19/2010

TUESDAY, Oct. 19 (HealthDay News) -- Kidney-failure patients can continue taking a group of widely used anemia drugs, even though a recent study showed they can increase the risk of stroke, U.S. health advisers said Monday.

A panel of U.S. Food and Drug Administration advisers voted 15-1, with one abstention, to maintain use of the drugs for patients with chronic kidney disease who aren't yet in need of dialysis, the Associated Press reported. The FDA is not required to follow the advice of its advisory panels, but typically does so.

The drugs -- Procrit, Aranesp and Epogen, a class of medications known as erythropoiesis-stimulating agents (ESAs) -- boost oxygen-carrying red blood cells, reducing the need for painful blood transfusions. But sales have fallen sharply since 2007, when the FDA added the first of several safety warnings to the drugs, based on evidence they can cause tumor growth and hasten death in cancer patients. The drugs are no longer used in patients with several types of cancers, the AP reported.

Labeling on the drugs currently advises doctors to maintain patients' hemoglobin levels -- a component of blood that carries oxygen -- between 10 grams and 12 grams per deciliter. The FDA asked the advisory panel if that recommendation should be lowered to 9 grams per deciliter. However, in a 9 to 5 vote, with 3 abstentions, a majority of panelists sided against that proposal. Those voting against the move expressed concern that patients would suffer more episodes of anemia, which involves weakness and shortness of breath and is a side effect of kidney failure and chemotherapy. They also worried that patients might require more blood transfusions if lower doses were recommended. They said physicians should instead manage patients based on their individual medical history, the AP reported.

The advisers said additional studies are needed to find the ideal drug dosage for kidney pati
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