The biotech company Celgene Corp. sent a letter to doctors on Wednesday of a study of the drug Innohep warns that it increases the risk of death in elderly patients.
The letter was posted late Wednesday on the Web site of the Food and Drug Administration. It recommends that physicians use alternative drugs to
Innohep when treating patients with deep vein thrombosis.
The warning comes after a European study of patients over 70 years of age with deep vein thrombosis and failing kidneys. The study, IRIS, was stopped in February 2008 after following 350 patients for three months. The patients who were given Innohep died of various causes at a rate of 13 percent compared to those given heparin's 5 percent.
Innohep has been available in Europe since 1991 and the United States since 2000. From 2001 to early 2007 more than 30 million patients in 60 countries had been treated with the injectable medicine.
Worldwide there have been 96 deaths and 383 reports of side effects.
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