FDA has received information about the clinical study: Innohep in Renal Insufficiency Study (IRIS) that was stopped in February, 2008 by the study’s Data Safety Monitoring Committee because of an interim finding of an increase in all-cause mortality in patients who received Innohep. This multi-center European study was designed to evaluate the safety of Innohep (tinzaparin), a low-molecular-weight heparin, compared to unfractionated heparin (UFH) in treating deep vein thromboses (DVT) and/or pulmonary emboli (PE) in patients greater than 70 years of age who had impaired renal function.