The FDA has received information about the Innohep in Renal Insufficiency Study (IRIS) that was stopped early because of an interim finding of increased all-cause mortality in patients who received Innohep (tinzaparin sodium injection, from Celgene). The preliminary data suggest that the increased risk of mortality is not only limited to patients ≥90 years of age. The FDA has requested that the company revise the labeling for Innohep to better describe the overall study results which suggest that, when compared to unfractionated heparin, Innohep increases the risk of death for elderly patients (i.e., ≥70 years of age) with renal insufficiency and deep vein thrombosis (DVT), pulmonary embolism (PE), or both.

Innohep is indicated for the treatment of acute symptomatic DVT with or without PE when administered in conjunction with warfarin sodium.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm090743.htm.