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 nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants. The risk also appears to be increased by traumatic or repeated epidural or spinal puncture. Patient should be frequently monitored for signs and symptoms of neurological impairment. If neurologic compromise is noted, urgent treatment is necessary. The physician should consider the potential benefit versus risk before intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis (see also WARNINGS, Hemorrhage and PRECAUTIONS, Drug Interactions ).
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warnings
WARNINGS General ORGARAN ® (danaparoid sodium) Injection is not intended for intramuscular administration. Since a specific standard for the anti-Xa activity of ORGARAN ® is used, the anti-Xa unit activity of ORGARAN ® is not equivalent to that described for heparin or low molecular weight heparin. Therefore, ORGARAN ® cannot be dosed interchangeably (unit for unit) with either heparin or any low molecular weight heparin. Miscellaneous ORGARAN ® (danaparoid sodium) Injection contains sodium sulfite which may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic patients. Hemorrhage Hemorrhage can occur at virtually any site in patients receiving ORGARAN ® (danaparoid sodium) Injection. An unexplained fall in hematocrit and/or fall in blood pressure should lead to serious consideration of a hemorrhagic event. ORGARAN ® , like anticoagulants, should be used with extreme caution in disease states in which there is increased risk of hemorrhage, such as severe uncontrolled hypertension, acute bacterial endocarditis, congenital or acquired bleeding disorders, active ulcerative and angiodysplastic gastrointestinal disease, non-hemorrhagic stroke, shortly after brain, spinal or ophthalmological surgery and post-operative indwelling epidural catheter use. Spinal or epidural hematomas can occur with the associated use of low molecular weight heparins or heparinoids and neuraxial (spinal/epidural) anesthesia or spinal puncture which can result in long-term or permanent paralysis. The risk of these events is higher with the use of post-operative indwelling epidural catheters or concomitant use of additional drugs affecting hemostasis such as NSAIDs (see boxed WARNING ).