FDA: Innohep Side Effects Could Increase Death Risk for Patients Over 70

The FDA has issued an early communication about an on-going safety review into potential side effects of Innohep, a low-molecular weight heparin. The agency has asked the drug maker to revise the warning label to indicate the Innohep death risk for elderly patients with renal insufficiency could extend to those 70 and older.

 
Innohep (tinzaparin) is an anti-coagulant or blood thinner manufactured by DuPont Pharma. The low-molecular weight heparin was approved by the FDA in 2000 to treat blood clots in patients with deep vein thrombosis (DVT) and pulmonary embolism (PE), and has been given to over 32 million people worldwide.

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.