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The announcement was made today during the annual meeting of the VenousDisease Coalition (VDC), an alliance of more than 30 leading healthprofessional societies and patient advocacy groups devoted to the prevention,early detection and prompt treatment of venous disease and its complications.
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"Hundreds of thousands of Americans develop deep vein thrombosis andpulmonary embolism each year, underscoring the need for greater awareness ofVTE," said Cynthia Schwalm, President, Eisai Inc. "We are pleased to supportthe Acting Surgeon General's recommendations calling for increased awarenessof DVT and PE, evidence-based practices for DVT and more research on thecauses, prevention and treatment of DVT."
Eisai Inc. markets FRAGMIN(R) (dalteparin sodium injection), approved bythe U.S. Food and Drug Administration (FDA) for prevention of DVT, which maylead to PE, in patients undergoing hip replacement surgery, in at-riskpatients undergoing abdominal surgery and in at-risk acutely ill patientswhose mobility is severely restricted. FRAGMIN(R) is also approved forprophylaxis of ischemic complications resulting from unstable angina and non-Q-wave myocardial infarction (heart attack), when used with aspirin.
In addition, FRAGMIN(R) is the only low molecular weight heparin (LMWH)approved in the United States for the extended treatment of symptomatic VTE(proximal DVT and/or PE) to reduce the recurrence of VTE in patients withcancer.
VTE is a frequent medical complication for patients with cancer, occurringin 4 to 20 percent of cases. Patients with cancer have an increased risk ofVTE compared to those without cancer. Additionally, patients with cancer maybe immobilized, which predisposes the patient to this condition.
Important Safety Information
SPINAL/EPIDURAL HEMATOMAS
When neuraxial anesthesia (epidural/spinal anesthesia) or spinal punctureis employed, patients anticoagulated or scheduled to be anticoagulated withlow molecular weight heparins or heparinoids for prevention of thromboemboliccomplications are at risk of developing an epidural or spinal hematoma whichcan result in long-term or permanent paralysis.
The risk of these events is increased by the use of indwelling epiduralcatheters for administration of analgesia or by the concomitant use of drugsaffecting hemostasis such as non steroidal anti-inflammatory drugs (NSAIDs),
platelet inhibitors, or other anticoagulants. The risk also appears to beincreased by traumatic or repeated epidural or spinal puncture.
Patients should be frequently monitored for signs and symptoms ofneurological impairment. If neurological compromise is noted, urgent treatmentis necessary.
The physician should consider the potential benefit versus risk beforeneuraxial intervention in patients anticoagulated or to be anticoagulated forthromboprophylaxis (also see WARNINGS, Hemorrhage and PRECAUTIONS, DrugInteractions in full prescribing information).
FRAGMIN(R) is contraindicated in patients with active major bleeding orwith known hypersensitivity to the drug, heparin, or pork products, or withthrombocytopenia associated with a positive anti-platelet antibody test.
Patients undergoing regional anesthesia should not receive FRAGMIN(R) forunstable angina or non-Q-wave myocardial infarction, and patients with cancerundergoing regional anesthesia should not receive FRAGMIN(R) for extendedtreatment of symptomatic VTE, due to an increased risk of bleeding associatedwith the dosage of FR
