Innohep Death Side Effects for Elderly Patients
Nearly one year after a clinical study was stopped early due to an apparent increase in all-cause mortality for patients given the anti-clot drug Innohep, Celgene Corp. has revised the warning label to indicate that elderly patients with renal insufficiencies may face an increased risk of death as a result of Innohep side effects.
>>FDA LINK: Innohep Side Effects
Innohep is a blood thinner or anti-coagulant prescribed to treat blood clots associated with pulmonary embolism, where a clot causes a sudden blockage of an artery which brings blood into the lungs, and deep vein thrombosis or DVT, which is a clot that forms in the deep veins of the legs, pelvis or arms.
In February 2008, a clinical study that was comparing the use of Innohep to unfractionated heparin among elderly patients 70 and older with kidney problems and DVT, was stopped early after data found that those treated with Innohep were dying at a much higher rate. Preliminary data found that after three months, 13% of those treated with Innohep died, compared with 5% of those treated with unfractionated heparin.
At first Celegen Corp. revised the warning label in July 2008 to indicate that Innohep side effects may increase the risk of death for patients 90 years of age or older. However, on December 2, 2008, the FDA indicated that they were requiring the drug maker to revise the label to better describe the overall study results and the increased risk of Innohep death for patients 70 years and older.
On December 31, 2008, a letter sent to healthcare providers by Celegen Corp was posted by the FDA. The letter describes the further label revisions, which now indicate that physicians should consider alternatives to Innohep when treating elderly patients with renal insufficiency for deep vein thrombosis, both with or without pulmonary embolism.
According to the letter:
Celgene distributed a letter on 28 July 2008 informing you of the revised label that reflected analysis of interim data from a clinical study (IRIS; Innohep in Renal Insufficiency Study). Our revised label highlighted the risks only for certain patients 90 years of age or older. We now regard the risks for Innohep as applying to all elderly patients with renal insufficiency and have further revised the label to include this information as a Warning.
The product liability lawyers at Saiontz & Kirk, P.A. are reviewing the potential for Innohep lawsuits on behalf of elderly patients 70 years of age or olded who died after receiving an injection of the blood thinner. Information surrounding the Innohep side effects will be evaluated to determine whether the drug maker may be liable for failing to provide adequate warnings about the risk of death.
To review a potential case on behalf of a friend or family member, request a free consultation.