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Wayne Parsons
Wayne Parsons
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FDA Adds Warning of Celgene's Risks For Elderly

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The Dow Jones (12/31, Dooren) reported, "The Food and Drug Administration said Wednesday Celgene Corp. (CELG) added an additional warning to its blood-clot busting drug Innohep stating it could increase the risk of death in elderly patients with kidney problems." This past "July the company said the risk appeared to apply to elderly patients age 90 and older and updated the drug’s label to warn of that risk" and "earlier this month, the FDA said the risk appeared for elderly patients age 70 and older and said it was asking Celgene to further revise the warning." In a letter that was posted on the FDA’s website from Celgen to doctors and other health professionals says, "we now regard the risks for Innohep as applying to all elderly patients with renal insufficiency and have further revised the label to include this information as a warning."

The AP (1/1, Johnson) reported, "The FDA said it had received 383 reports of side effects and complications worldwide, including 96 deaths, as of Oct. 15, 2008," and it "expects to get a final report from the study in January and will complete its review soon after that."