Saturday, January 3, 2009

FDA Alert: Innohep (12/31/08)

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