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| |  FDA Approves Fragmin (Dalteparin) For Prevention Of Deep Vein Thrombosis Post-Op PEAPACK, NJ -- August 7, 2000 -- Pharmacia Corporation announced that the U.S. Food and Drug Administration (FDA) has approved a post-operative once-daily dosing regimen for the anti-clotting agent Fragmin® (dalteparin sodium injection) for the prevention of blood clots (known as deep vein thrombosis) following hip replacement surgery. Fragmin is the first and only low molecular weight heparin (LMWH) approved for this dosing regimen. The study supporting the approval showed that Fragmin administered in the post-operative period following hip replacement surgery was more effective than warfarin -- a standard treatment -- in preventing deep vein thrombosis. More than 280,000 people undergo hip replacement each year, with potentially fatal blood clots occurring in up to 60 percent of these patients, if left unprotected. "Doctors would prefer to give anticoagulation therapy in the post-operative period after hip replacement rather than before surgery to reduce the risk of bleeding due to anticoagulation effects during surgery," said David C. Ayers, MD, director of joint replacement surgery and associate professor of orthopedic surgery, Upstate Medical University, Syracuse, NY. "Fragmin given post-operatively provided the efficacy in reducing blood clots that physicians want, and demonstrated a low incidence bleeding." The revision to the product's label allows physicians to initiate the once-daily dose (within four to eight hours) post-operatively, and continue treatment for up to 14 days (usual duration was five to 10 days). The landmark multi-center, double-blind, randomized study, North American Fragmin Trial (NAFT), evaluated the incidence of deep vein thrombosis in 1,472 patients treated with Fragmin started either pre-operatively or post-operatively, or warfarin, for six days. Results showed that initiating the first dose of Fragmin post-operatively was as effective in reducing the risk of deep vein thrombosis as Fragmin dosed pre-operatively. Both dosing regimens were more effective than warfarin in reducing the incidence of thromboembolic events following hip replacement surgery. The incidence of deep vein thrombosis in both groups treated with Fragmin was lower than in patients receiving warfarin (13.1 percent post-operative, 10.7 percent pre-operative, 24 percent warfarin). There was a relative risk reduction of 72 percent in proximal deep vein thrombosis (0.8 percent post-operative, 0.8 percent pre-operative, 3 percent warfarin) and a 45 percent relative risk reduction in total deep vein thrombosis with Fragmin post-operative dosing versus warfarin. Proximal deep vein thrombosis, clots in blood vessels in the upper legs or pelvis, is associated with a greater risk of pulmonary embolism, which reduces the patient's oxygenated blood flow to the heart and brain, and can cause death. The incidence of investigator reported serious bleeding events was similar in all three treatment groups (1.0 percent post-operative, 2.0 percent pre-operative, 1.6 percent warfarin). Deep vein thrombosis affects up to 60 percent of patients who undergo hip replacement surgery without preventative therapy. It occurs when blood clots form in a vein in the pelvis or legs; in some cases the clot can dislodge and travel to the lung arteries, resulting in pulmonary embolism. More than 40 million patients worldwide have received low molecular weight heparin (LMWH) Fragmin. Fragmin is contraindicated in patients with active major bleeding or a known hypersensitivity to the drug or active major bleeding, and should be used with extreme caution in patients with history of thrombocytopenia (low platelet count) or with an increased risk of hemorrhage. Spinal or epidural hematomas can occur with the associated use of low molecular weight heparins or eparinoids and neuraxial anesthesia or spinal puncture, which can result in long-term or permanent paralysis. Related Links: Fragmin (dalteparin) and Pharmacia Corporation.
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