Biologic drugs for treatment of anemia made by Amgen will be restricted for kidney dialysis patients if they raise hemoglobin beyond a certain level, the U.S. Medicare health insurance program announced on July 20th.

The policy, designed to reduce potential risks, will impose greater restrictions on dosages of Epogen and Aranesp when a patient's level of hemoglobin exceeds 13 grams per deciliter of blood, according to the Centers for Medicare and Medicaid Services.

The drugs are approved by the U.S. Food and Drug Administration to restore hemoglobin to 12 grams a deciliter of blood, and current Medicare policy states that a dialysis patient’s hemoglobin range, which measures the extent of a patient’s anemia, should be maintained between 10 and 12 g/dL.

The restrictions were widely expected following reports earlier this year that the erythropoiesis-stimulating agents, or ESAs, increased the risk of heart attacks, strokes and death at high doses for kidney patients taking part in studies.

"In response to safety concerns, we are modifying the ESA monitoring policy to provide greater restrictions on the dosage amounts of ESAs for which payment is made" for patients with hemoglobin levels above 13 grams per deciliter, Medicare said.

“We feel strongly that these revisions will support the clinically sound and prudent management of anemia in dialysis patients,” said Dr. Barry Straube, chief CMS medical officer who is also a nephrologist.

Two FDA advisory committees, meanwhile, will meet in September to further consider the safety of the Amgen drugs and Johnson & Johnson's Procrit when used in kidney patients with anemia.

In a Federal Register notice, the FDA said it would convene a joint meeting of its cardiovascular and renal drugs advisory committee and the drug safety and risk management advisory committee on Sept. 11 to discuss "updated information on the risks and benefits" of Aranesp, Epogen and Procrit .