January 1, 2009
Celgene, FDA: Doctors Should Look For Alternatives To Blood Clot Drug
The FDA posted a letter to its Web site on Wednesday from Celgene Corp. warning users of blood-clot busting drug Innohep that new findings suggest the drug may lead to death in the elderly.
The letter urges doctors to suggest alternative drugs for patients with a blood clot condition known as deep vein thrombosis due to newly-reported findings from Europe that suggest patients 70 years and older who took Innohep may be susceptible to kidney failure.
"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," Celgene said.
When the study was ended in February 2008, 13 percent of 350 patients had died of various causes.
"From the information currently available to FDA, there is no clear pattern as to the causes of death," the FDA said in a statement.
Only 5 percent of the study's comparison group died from clot-busting heparin.
The agency said available data cannot rule out the possibility that patients in the Innohep group suffered another deep vein blood clot or that there was a problem in manufacturing of the drug.
Innohep has been sold in Europe since 1991 and was approved for U.S. sales in 2000.
From early 2001 through early 2007, more than 30 million people in 60 countries were treated with the drug.
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