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FDA Seeks Labeling Cchanges for Innohep

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The Food & Drug Administration (FDA) has warned that Innohep (tinzaparin) may increase the risk of death in elderly patients (over 70), and has asked the drug’s manufacturer to revise the Innohep label to reflect this risk.

In an alert released yesterday, the FDA said it had received information about a clinical study known as Innohep in Renal Insufficiency Study (IRIS) that was stopped in February, 2008.  The study’s Data Safety Monitoring Committee had halted the IRIS trial 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, a low-molecular-weight heparin, compared to unfractionated heparin  in treating deep vein thromboses (DVT)  and/or pulmonary emboli (PE) in patients greater than 70 years of age who had impaired renal function.

At the time the study was stopped, 350 patients had completed 90 days follow-up. Of these, 23 of the 176 (13%) patients in the Innohep treated group and 9 of the 174 (5%) patients in the unfractionated heparin treated group had died. From the information currently available,  there is no clear pattern as to the causes of death. The causes of death do not appear to be related to either over-dosing (bleeding) or under-dosing (blood clots) with an anti-coagulant (a blood thinner), the FDA said.

The FDA is concerned that the preliminary data from the IRIS study suggest that the increased risk of death is not limited only to patients 90 years of age or older. The agency has requested that the company revise the labeling for Innohep to better describe the overall IRIS 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 and older) with renal insufficiency.   The FDA said Pharmion Corp., the maker of Innohep, already revised the Innohep label this past July to restrict prescribing in patients 90 and older.

The FDA says healthcare professionals should consider the use of alternative treatments to Innohep when treating elderly patients over 70 years of age with renal insufficiency and DVT, PE, or both.  The FDA is also urging both healthcare professionals and patients to report side effects from the use of Innohep to the FDA’s MedWatch Adverse Event Reporting program.

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