Tinzaparin (Innohep) use associated with higher mortality rate in elderly with renal insufficiency

Henry I. Bussey, Pharm.D., FCCP, FAHA
December, 2008

On December 2, 2008, the FDA at www.fda.gov/medwatch/safety/2008/safety08.htm#Innohep posted a warning regarding the use of tinzaparin (Innohep) in elderly patients with renal insufficiency and cite a study which was terminated early because of an increased mortality rate in such patients compared to those receiving unfractionated heparin. Little information is available at this time as to the cause(s) of death, whether there may have been a problem with the source of tinzaparin, and/or whether or not the dose of tinzaparin was adjusted for renal function or whether potential accumulation of the drug was evaluated. More data should be forthcoming as the FDA-ordered review is completed and the data published.