Blood Thinner Cleared by FDA for the Acutely Ill

A blood-thinning agent has been cleared by the U.S. Food and Drug Administration (FDA) for the prevention of deep-vein thrombosis in patients who are at risk for thromboembolic complications due to severely restricted mobility during an acute illness.

A multicenter study has shown that the blood thinner, a low-molecular-weight heparin called enoxaparin sodium (Lovenox), is effective in reducing the risk of venous thromboembolism (VTE). The study included patients who were initially bedridden and suffering from heart failure, acute respiratory failure, acute infectious disease, or acute rheumatic disorder.

The incidence of VTE was significantly lower in patients treated with enoxaparin, compared with those treated with placebo (4.4% vs. 11.9%). Like other low-molecular-weight heparins, enoxaparin should be used with extreme caution in patients with a history of heparin-induced thrombocytopenia.Enoxaparin is the product of Aventis Pharma (Frankfurt, Germany).

"Lovenox has a proven track record of success with caregivers and patients, and we anticipate that this new use will further establish its unique position in the clinical environment,” said Gerald P. Belle, president, Aventis Pharmaceuticals, North America.