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).
In early December, the FDA announced that it had received information about the Innohep in Renal Insufficiency Study (IRIS) that was stopped in February because of an interim finding of increased mortality in elderly patients.
As a result, in July, the company revised the prescribing information to restrict the use of Innohep in patients 90 years of age and older. However, preliminary data from IRIS suggests that the increased risk of mortality is not only limited to patients in that age range. Study results suggest that compared to unfractionated heparin, Innohep increases the risk of death for patients 70 years and older with renal insufficiency and deep vein thrombosis (DVT), pulmonary embolism (PE), or both. The FDA suggested health care professionals consider the use of alternative treatments for patients older than 70 years of age with those conditions.
The FDA says it anticipates submission of the final IRIS study report sometime in January and will complete its review soon thereafter. Additional regulatory actions as appropriate will be considered after thorough review of all applicable data from the manufacturer of Innohep.