Monday, December 08, 2008

Tinzaparin Associated with Increased Mortality Risk in Elderly Patients with Renal Insufficiency

08 dec 2008--Tinzaparin (Innohep), a low-molecular-weight heparin, may be associated with an increased mortality risk in patients aged 70 or older who have renal insufficiency, the FDA cautioned on Tuesday.

The warning follows the early termination of a European study testing the safety of tinzaparin versus unfractionated heparin to treat deep venous thrombosis, pulmonary emboli, or both in elderly patients with renal insufficiency. The trial was stopped in February because of a higher rate of all-cause mortality in patients given tinzaparin, compared with unfractionated heparin (13% vs. 5%).

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FDA alert (Free)

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