Innohep Lawsuits

Side effects of Innohep, a low molecular weight heparin, have been linked to an increased risk of death when used to treat deep vein thrombosis (DVT) or pulmonary embolism among patients with impaired renal function who are 70 years old or older.

INNOHEP LAWSUIT STATUS: The potential for legal claims are being evaluated on behalf of individuals who were 70 or older, with impaired renal function, who suffered from Innohep death side effects.

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MANUFACTURER: DuPont Pharma

OVERVIEW: Innohep (tinzaparin) is a low molecular weight heparin, which is an anti-coagulant or blood thinner, administered as a subcutaneous injection. It was approved in the United States in 2000 for treatment of blood clots in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE). Over 32 million people have been given the blood thinner throughout the United States.

In February 2008, a clinical study was stopped early after it was discovered that Innohep side effects could increases the risk of death among patients 70 years old and older given the blood thinner.

INNOHEP DEATH SIDE EFFECTS: In December 2008, the FDA issued an early communication about a potential increased risk of death with Innnohep. After reviewing preliminary data from the IRIS study (Innohep in Renal Insufficiency Study), the agency indicated that they asked the drug maker to revise the warning label to indicate that when compared to unfractionated heparin, Innohep increases the risk of death for elderly patients (those 70 years of age and older) with renal insufficiency.

The IRIS study was stopped early in February 2008 after researchers discovered that participants given Innohep faced an increase in all-cause mortality. The study was designed to compare the use of unfractionated heparin to Innohep among patients over 70 years old with renal impairment.

When the IRIS study was stopped, 350 patients had completed a follow up period of 90 days. Out of the 176 patients who were treated with Innohep, 23 died within 90 days (13%), compared to only 9 out of 174 (5%) treated with unfractionated heparin.

The exact causes of death were not clear, but they were apparently not related to either under-dosing (blood clots) or over-dosing (bleeding) with the blood thinners. A manufacturing problem with either Innohep or UFH was also not indicated.

INNOHEP WARNINGS: In July 2008, the manufacturer of Innohep changed the warning label to restrict use of the blood thinner to those under 90 years old. However, in December 2008, the FDA indicated that they are asking that the label be revised to better reflect the preliminary data from the IRIS study, which suggests the death risk is not limited to those over 90 years old.

On December 31, 2008, a letter was posted on the FDA website from Celgene Corp., which sells Innohep in the United States, recommending that doctors consider alternative drugs for all elderly patients with kidney problems due to the Innohep death risks identified in the IRIS study.