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FDA Panel Supports Anemia Drugs for Cancer Patients
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Page: << Prev | 1 | 2 | 3 And last week, Amgen agreed to expand the "black box" warning on all three drugs to include information about tumor growth and death in patients with early-stage breast cancer and cervical cancer. Johnson & Johnson markets Procrit in an agreement with Amgen, the Wall Street Journal reported.
When Procrit was first approved in 1989, the drug was touted as a treatment to lessen fatigue and improve quality of life among cancer and HIV patients with anemia, but the revised label states there was no evidence to back that claim. The label change was the fifth such change since Procrit's approval, FDA officials said.
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For more on ESAs, go to the U.S. Food and Drug Administration.
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Copyright © 2008 ScoutNews, LLC. All rights reserved.
Last updated 3/13/2008
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SOURCES: Samuel M. Silver, M.D., Ph.D., spokesman, American Society of Hematology; March 13, 2008, statement, Amgen Inc.; March 11, 2008, briefing documents, U.S. Food and Drug Administration; March 12, 2008, statement, Johnson & Johnson; March 13, 2008, Wall Street Journal
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