Innohep (tinzaparin) is a low-molecular weight heparin used as a blood thinner or anti-coagulant. It was approved in 2000 by the FDA to treat blood clots in patients with pulmonary embolism (PE) and deep vein thrombosis (DVT).

Since it was first introduced in Europe in 1991, over 30 million people in 60 countries have received Innohep injections.

Concerns about side effects of Innohep surfaced after preliminary results were released from a clinical study known as IRIS (Innohep in Renal Insufficiency Study), which involved the study of the drug among patients 70 years of age and older who had deep vein thrombosis and failing kidneys.

The study, which was designed to compare the effects of Innohep and unfractionated heparin (UFH), was stopped in February 2008, after early data suggested an apparent increase in all-cause mortality among patients given Innohep.

Out of 176 patients treated with Innohep, 23 died after three months (13%), compared with only 9 out of 174 patients treated with UFH (5%).

Celgene Corp., which sells Innohep in the United States, sent a letter to doctors in July 2008 advising them of revisions to the drug’s warning label which indicated that Innohep increases the risk of death in patients 90 years of age and older. However, the drug maker now acknowledges that the Innohep death risk applies to all elderly patients with renal insufficiency.

A new letter sent to healthcare providers was posted by the FDA on December 31, 2008, where Celegene now recommends that physicians consider Innohep alternatives when treating deep vein thrombosis (DVT), with or without pulmonary embolism, in elderly patients with renal insufficiencies.

The revised warnings about the risk of death with Innohep were issued after the FDA requested the drug maker update the label to better describe the overall results of the IRIS study.

As of October 15, 2008, the FDA has received 383 reports worldwide of Innohep side effects and complications, including at least 96 Innohep deaths.

In early December 2008, the FDA indicated that they expect to receive the final IRIS study report this month, and plan to complete their review of the Innohep death risk soon thereafter. The FDA has indicated that they will consider whether additional regulatory action is appropriate after a review of all applicable data from the manufacturer of Innohep.

The FDA issued an early communication yesterday about Innohep side effects after receiving data from a clinical study which suggested that the blood thinner may increase the risk of death for patients over 70 years old with impaired renal function who were given the drug to treat deep vein thrombosis (DVT) or pulmonary embolism.

The study, called Innohep in Renal Insufficiency Study (IRIS), was stopped early in February 2008 after researchers identified an increase in all-cause mortality among participants given innohep.

The study was designed to compare the use of Innohep to unfractionated heparin (UFH), but the study was stopped because 23 of the 176 patients who had been treated with Innohep died after 90 days, compared with 9 out of 174 treated with UFH.

In July 2008, the drug maker changed the labeling to restrict use of Innohep in patients 90 years of age and older, but the FDA indicates that preliminary data from the IRIS study suggest that the Innohep death risk is not limited to those over 90 years old.

According to the FDA early communication released on December 2, 2008, the agency “has requested that the [drug maker] revise the labeling for Innohep to better describe the overall study results which suggest that, when compared to UFH, Innohep increases the risk of death for elderly patients (i.e. 70 years of age and older) with renal insufficiency.”

An FDA early communication does not mean that the regulatory agency has concluded that there is a cause and effect relationship, but that they are continuing to review the emerging safety issue.

The FDA expects to complete its final review of the data about the Innohep death side effects by January 2009, after which it will determine what, if any, further regulatory action is needed. Until then, the FDA indicates that healthcare providers should consider the use of alternative drugs to Innohep for treatment deep vein thrombosis and/or pulmonary embolism among patients who are over 70 years old with renal impairment.

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.

>>SUBMIT INFORMATION ABOUT A POTENTIAL INNOHEP LAWSUIT FOR REVIEW BY AN ATTORNEY<<

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.