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The FDA said it had received 383 reports of side effects and complications worldwide, including 96 deaths, as of Oct. 15, 2008.
Late last July, Celgene sent another letter to doctors warning of an elevated risk of death in patients aged 90 and older. The new letter extends the warning to all elderly patients.
The FDA statement Wednesday said the agency has asked the company to revise the package insert, or label, "to better describe the overall study results which suggest that, when compared to (heparin), Innohep increases the risk of death for elderly patients" with failing kidneys.
The agency said it expects to get a final report from the study in January and will complete its review soon after that.
Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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