Celgene's Innohep risky for elderly

Trenton, New Jersey, January 4: Celgene Corp.’s Innohep, a drug used to treat blood clots commonly formed in deep veindefine thrombosisdefine, may actually heighten death rate among elderly patients as it makes them more susceptible to a rare kind of kidney failure, the drug maker announced.

The results of the latest clinical trials unfolded a rather ‘statistically significant’ death incidence among Innohep users -13 percent as compared to a death rate of 5 percent in those put on Heparin, another anti-clotting drug.

Following study results, the pharma giant in association with the U.S. drug watchdog, the Food and Drug Administration, have urged doctors to seek alternative drugs for patients with a blood clot condition known as deep veindefine thrombosisdefine, a life-threatening condition characterized by blood clots in major veins, especially in legs.

The drug maker has also put up a letter on the FDA’s official website stating study facts and recommending alternative drug use.

While the increased death risk associated with the drug use is already documented for patients above 90 years, the latest letter extends the warning to ‘all elderly patients’, the details enlist.

Innohep, though already available in the European markets since 1991, was approved for U.S. sales in 2000. However, since approval, nearly 383 cases of adverse reactions associated with drug use have been reported, including 96 deaths.

The latest study, the IRIS, involved 350 patients with deep vein thrombosis. Patients, all above 70 years, were randomly assigned to receive either a shot of Innohep or a similar anticoagulant, Heparin.

With a 13 percent death rate among patients put on Innohep, the study was halted midway in February 2008. Conversely, the death rate in the group receiving Heparin was 5 percent.

As patients in the Innohep group had died of various causes, no single cause of death could be picked, the drug maker revealed.

As of now, the FDA has instructed Celgen to revise the information on the drug’s package insert “to better describe the overall study results which suggest that, when compared to (heparin), Innohep increases the risk of death for elderly patients with failing kidneys.”