Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

A group of blood thinners used to reduce the risk of deep vein blood clots in patients has updated their products’ safety labeling and revised the boxed warning to include a risk of epidural or spinal hemotomas in some patients, according to an announcement by the Food and Drug Administration (FDA). The FDA places boxed warnings, also known as black box warnings, on drugs that, based on medical studies, carry a significant risk of serious adverse side effects or death.

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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 death in elderly patients who received Innohep. Innohep contains tinzaparin sodium that is given to patients in conjunction with warfarin sodium intravenously to treat blood clots that have occurred deep in the veins of hospitalized patients who may or may not have also experienced the occurrence of blood clots in their lungs (pulmonary embolism).

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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 blood clots that have occurred deep in the veins of hospitalized patients who may or may not have also experienced the occurrence of blood clots in their lungs (pulmonary embolism).

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