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Anemia drugs could face tougher warnings

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Published: May 10, 2007 at 10:56 AM

WASHINGTON, May 10 (UPI) -- An advisory panel to the U.S. Food and Drug Administration was set to meet Thursday on whether anemia drugs like Amgen's Aranesp increase patients' tumor risk.

The panel will consider new information on the class of anemia drugs known as erythropoeisis-stimulating agents -- which also includes Amgen's Epogen and Johnson & Johnson's Procrit -- used to treat anemia caused by chemotherapy for cancer.

FDA officials say they are concerned about several new studies suggesting that the injectable treatments may pose a higher risk of tumor growth or death particularly when used in patients off-label, or beyond the drugs' FDA-approved use.

However, the agency said it also wants advice from the panel on whether patients receiving Aranesp or Procrit are at higher risk even when the drugs are prescribed for their approved uses.

FDA is not bound to follow the recommendations of its expert panels, but does so in most cases.

© 2007 United Press International, Inc. All Rights Reserved. Any reproduction, republication, redistribution and/or modification of any UPI content is expressly prohibited without UPI's prior written consent.

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