Innohep FDA warning

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Ross

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Innohep (tinzaparin sodium injection)

Audience: Hematological and Nephrological healthcare professionals, hospital risk managers
[UPDATE 12/31/2008] Celgene has issued a Dear Healthcare Professional letter describing a controlled clinical study suggesting that Innohep may increase the risk for death, compared to unfractionated heparin when used to treat elderly patients with renal insufficiency. It recommended consideration of alternatives to Innohep when treating these patients for deep vein thrombosis with or without pulmonary embolism.

Read the complete MedWatch 2008 Safety summary, including a link to the Dear Healthcare Professional letter and the December 2 FDA Ongoing Safety Review, at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Innohep


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You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
 
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