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Anemia drugs to get new labeling warning of potential danger in off-label use.
Byline: Allison Bruce
Mar. 10--Warning labels on anemia-fighting drugs produced by Amgen Inc. will be changed to reflect concerns that have arisen from recent studies.
The U.S. Food and Drug Administration announced Friday that it will include a warning on the prescribing information for the anemia drugs Procrit, Epogen and Aranesp. It notes "patients should be informed of the increased risks of mortality, serious cardiovascular events, thromboembolic events, and tumor progression when used in off-label dose regimens or populations."
Thousand Oaks-based Amgen and the FDA agreed on the labeling changes to update and modify the warnings and dosing instructions.
Aranesp is approved for use in cancer patients undergoing chemotherapy and patients with chronic kidney disease either with or without dialysis. Epogen is…
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Source: HighBeam Research, Anemia drugs to get new labeling warning of potential danger in...
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