Tinzaparin increases mortality risk in elderly patients

FDA announced that the agency is evaluating data from a clinical study in which all-cause mortality was increased among patients treated with tinzaparin (Innohep, Celgene) versus patients treated with unfractionated heparin (UFH).

FDA announced that the agency is evaluating data from a clinical study in which all-cause mortality was increased among patients treated with tinzaparin (Innohep, Celgene) versus patients treated with unfractionated heparin (UFH).

The study assessed the use of tinzaparin for the treatment of deep vein thromboses (DVT) in patients aged at least 70 years who had impaired renal function. In February 2008, the study’s data safety monitoring committee stopped the trial when an interim analysis demonstrated that 13% of tinzaparin-treated patients and 5% of UFH-treated patients had died. In July 2008, the manufacturer revised the labeling information for tinzaparin to restrict use of this agent in patients aged 90 years or older. The manufacturer has now updated the label to warn of the increased mortality risk associated with tinzaparin treatment in all elderly patients with renal insufficiency.

FDA stated that the agency will consider additional regulatory actions after it has analyzed all of the available data.