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FDA Orders Labeling Changes for Anemia Drugs

The U.S. Food and Drug Administration (FDA) has ordered Amgen to make labeling changes to two drugs used for the treatment of anemia. Prescribing information for Aranesp and Procrit must now include warnings on the risk that the drugs may actually worsen the effects of cancer when administered to patients undergoing chemotherapy.

In a letter to Amgen, the FDA stated that the new labeling must "address the risk of increased mortality and/or poorer tumor outcomes" in patients being treated for certain types of cancer. As the New York Times reports, this marks the first time the FDA has acted under authority provided by a 2007 amendment to the Federal Food, Drug, and Cosmetic Act, which gives the agency the power to order labeling changes for prescription medications. "Previously, the F.D.A. could only negotiate with a drug?s manufacturer to change the label," according to the Times.

• FDA Labeling Change Order and Medication Guide for Aranesp [PDF files]
• FDA Labeling Change Order and Medication Guide for Procrit [PDF files]
• N.Y. Times: Amgen Told to Reword Drug Label
• Federal Food, Drug, and Cosmetic Act (FDA)
• Pharmaceutical Drug Liability (FindLaw)
• Things You Should Know: Taking Prescription Medications (FindLaw)

Full post as published by FindLaw's Common Law on July 31, 2008 (boomark / email).