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Eisai Inc. Supports Acting Surgeon General's Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism
Date:9/15/2008

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VTE is a frequent medical complication for patients with cancer, occurring in 4 to 20 percent of cases. Patients with cancer have an increased risk of VTE compared to those without cancer. Additionally, patients with cancer may be immobilized, which predisposes the patient to this condition.

Important Safety Information

SPINAL/EPIDURAL HEMATOMAS

When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low molecular weight heparins or heparinoids for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis.

The risk of these events is increased by the use of indwelling epidural catheters for administration of analgesia or by the concomitant use of drugs affecting hemostasis such as non steroidal anti-inflammatory drugs (NSAIDs),

platelet inhibitors, or other anticoagulants. The risk also appears to be increased by traumatic or repeated epidural or spinal puncture.

Patients should be frequently monitored for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.

The physician should consider the potential benefit versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis (also see WARNINGS, Hemorrhage and PRECAUTIONS, Drug Interactions in full prescribing information).

FRAGMIN(R) is contraindicated in patients with active major bleeding or with known hypersensitivity to the drug, heparin, or pork products, or with thrombocytopenia associated with a positive anti-platelet antibody test.

Patients undergoing regional anesthesia should not receive FRAGMIN(R) for unstable angina or non-Q-wave myocardial infarction, and patients with cancer undergoing regional anesthesia should not receive FRAGMIN(R)
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SOURCE Eisai Inc.
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