US FDA orders Amgen to change anemia drug label

By Lisa Richwine

WASHINGTON (Reuters) - U.S. health officials are ordering Amgen Inc (AMGN.O) to change the prescribing instructions for Aranesp and similar anemia drugs to address concerns about the risks to cancer patients.

The labels for the drugs now must say they are not indicated for patients undergoing chemotherapy with the intention to cure the patient, Dr. Richard Pazdur, head of the Food and Drug Administration office that reviews cancer therapies, said on Wednesday.

The instructions also will say treatment with the drugs should not be started if patients' hemoglobin levels are greater than, or equal to, 10 grams per deciliter.

The changes apply to Amgen's Aranesp and Procrit, which is sold by Johnson & Johnson (JNJ.N) under a license from Amgen. The drugs are known as erythropoiesis-stimulating agents, or ESAs.

The FDA and Amgen reached agreement on all but two changes to the drug labels, Pazdur said. The agency ordered Amgen to make all of the revisions, the first time it has invoked new powers granted last year to force companies to amend labels.

Amgen said in a statement the label changes were consistent with the company's expectations and the potential impact was factored into guidance issued on Monday.

Amgen markets another ESA drug called Epogen for kidney disease patients.

Amgen shares gained 2 cents to close at $62.30 on Nasdaq. Johnson & Johnson shares fell 40 cents to close at $68.08 on the New York Stock Exchange.

(Reporting by Lisa Richwine; Editing by Tim Dobbyn and Andre Grenon )