Innohep (Tinzaparin) Linked to Increased Death

FDA Requests Labeling Change

The FDA has issued a notification regarding the safety of the anticoagulant Innohep (tinzaparin sodium injection). The alert is based on information from the European IRIS study, which was stopped in February 2008, due to a finding of increased all-cause mortality in patients given the low molecular weight heparin.

Innohep was approved for use in the United States in July, 2000. In the period from March 1, 2001 to February 28, 2007 roughly 32.1 million people in 60 countries were treated with Innohep. The FDA Adverse Event Reporting System was searched on October 15, 2008 and identified 383 adverse events reports of all types worldwide with 96 having death as an outcome. Overall, 60 of the 383 reports were from the USA, including 6 deaths (ages 60 – 75).

The FDA has asked the company that makes Innohep to revise its labeling to include the overall study results which suggest that compared to unfractionated heparin, Innohep increases the risk of death for elderly patients (i.e., 70 years of age and older) with renal insufficiency. This will be the second labeling alteration for the drug. In July 2008, the company revised the prescribing information to restrict the use of Innohep in patients 90 years of age or older.

Dec-02-08: Innohep (Tinzaparin) Safety Review

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Last updated on Apr-7-10