The blood thinners included in this announcement include Arixtra (fondaparinux sodium) Solution for subcutaneous injection; Fragmin (dalteparin sodium injection) for Subcutaneous Use; Innohep (tinzaparin sodium) injection; and Lovenox (enoxaparin sodium) injection for subcutaneous and intravenous use.

The new warning states that epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Health care professionals are asked to consider these risks when scheduling patients for spinal procedures.

Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

• Use of indwelling epidural catheters
• Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants.
• A history of traumatic or repeated epidural or spinal punctures
• A history of spinal deformity or spinal surgery

Health care providers are encouraged to monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Benefits and risks should be weighed before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

SOURCE: Heparin Recall › Revised boxed warning placed on blood thinners