News Tagged ‘IRIS

Celgene issues letter warning of limited use of heparin drug

Just weeks after the FDA requested revised labeling for the low molecular weight heparin, Innohep, the FDA announced that its maker Celgene Corporation has issued a “Dear Healthcare Professional” letter describing a controlled clinical study that suggests an increased risk of in elderly patients who received Innohep. Innohep contains tinzaparin sodium that is given to patients in conjunction with warfarin sodium intravenously to treat that have occurred deep in the veins of hospitalized patients who may or may not have also experienced the occurrence of in their lungs (pulmonary embolism).

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FDA requests better labeling of low molecular weight heparin

The FDA announced this week that it has received information about the Innohep in Renal Insufficiency Study (IRIS) that was stopped in February because of an interim finding of increased all-cause mortality in patients who received Innohep. Innohep contains tinzaparin sodium, a low molecular weight heparin that is given to patients in conjunction with warfarin sodium intravenously to treat that have occurred deep in the veins of hospitalized patients who may or may not have also experienced the occurrence of in their lungs (pulmonary embolism).

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