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FDA Drug Safety Podcast: Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins

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Narrator: Welcome to the FDA Drug Safety Podcast. Today’s topic: Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins.

Karla Waters, a Consumer Safety Officer in the division, will provide you with additional information about this communication.

Speaker: On November 6th, 2013 the FDA issued a Drug Safety Communication recommending health care professionals to carefully consider the timing of spinal catheter placement and removal in patients taking anticoagulant drugs, such as enoxaparin, and delay dosing of anticoagulant medications for some time interval after catheter removal to decrease the risk of spinal column bleeding and subsequent paralysis after spinal injections, including epidural procedures and lumbar punctures. These new timing recommendations, which can decrease the risk of epidural or spinal hematoma, will be added to the labels of anticoagulant drugs known as low molecular weight heparins including Lovenox, generic enoxaparin products, and similar products.

Health care professionals and institutions involved in performing spinal/epidural anesthesia or spinal punctures should determine, as part of a preprocedure checklist, whether a patient is receiving anticoagulants and identify the appropriate timing of enoxaparin dosing in relation to catheter placement or removal. To reduce the potential risk of bleeding, consider both the dose and the elimination half-life of the anticoagulant:

  • For enoxaparin, placement or removal of a spinal catheter should be delayed for at least 12 hours after administration of prophylactic doses such as those used for prevention of deep vein thrombosis. Longer delays (24 hours) are appropriate to consider for patients receiving higher therapeutic doses of enoxaparin (1 mg/kg twice daily or 1.5 mg/kg once daily).
  • A postprocedure dose of enoxaparin should usually be given no sooner than 4 hours after catheter removal.
  • In all cases, a benefit-risk assessment should consider both the risk for thrombosis and the risk for bleeding in the context of the procedure and patient risk factors.

Epidural or spinal hematomas are a known risk for enoxaparin in the setting of spinal procedures and are already described in the Boxed Warning and the Warnings and Precautions sections of the labels for Lovenox and generic enoxaparin products. However, these serious adverse events continue to occur. To address this safety concern, FDA worked with the manufacturer of Lovenox, Sanofi-Aventis, to further evaluate this risk and to update the Warnings and Precautions section of the Lovenox label with these additional timing recommendations. The labels for generic enoxaparin products will also be revised accordingly, as will those of other low molecular weight heparin-type products.

Before undergoing an epidural or spinal procedure, patients should inform their health care professional if they are taking any anticoagulant drugs. When undergoing these types of procedures, patients should alert their health care professional immediately if they experience any symptoms such as numbness, tingling, leg weakness or paralysis, or loss of control over their bladder or bowels.

It is important to note that all anticoagulants carry the risk of causing spinal bleeding when used in conjunction with epidural/spinal anesthesia or spinal puncture. We are continuing to evaluate the safety of other anticoagulants to determine if additional label changes are needed.

At this time FDA recommends health care professionals to be aware of the following:

  • Cases of epidural or spinal hematomas continue to be reported with the use of enoxaparin (Lovenox or its generics) and other low molecular weight heparins and spinal/epidural anesthesia or spinal puncture procedures, resulting in long-term or permanent paralysis.
  • Health care professionals and institutions involved in performing spinal/epidural anesthesia or spinal punctures should determine, as part of a preprocedure checklist, whether a patient is receiving anticoagulants and identify the appropriate timing of enoxaparin or other anticoagulant dosing in relation to catheter placement/removal.
  • The placement and removal of the catheter is best performed when the anticoagulant effect of enoxaparin is low (considering the dose of anticoagulant and its elimination half-life) to reduce the potential risk of bleeding associated with the concurrent use of enoxaparin and epidural or spinal anesthesia/analgesia. Although no prospective trials of this timing have been performed to date, additional guidance is being provided now for considerations that may reduce the risk.
  • Placement or removal of a catheter should usually be delayed for 12 hours after administration of deep vein thrombosis (DVT) prophylactic doses of enoxaparin, whereas patients receiving higher doses of enoxaparin (1 mg/kg twice daily or 1.5 mg/kg once daily) will require longer delays (24 hours). The subsequent enoxaparin dose should usually be given no sooner than 4 hours after catheter removal.
  • In all cases, a benefit-risk assessment should consider both the risk for thrombosis and the risk for bleeding in the context of the procedure and patient risk factors.
  • If anticoagulation is administered in the setting of epidural/spinal anesthesia, monitor patients frequently to detect any signs and symptoms of neurological impairment, such as midline back pain, sensory and motor deficits such as numbness or weakness in lower limbs, and bowel and/or bladder dysfunction.
  • Counsel patients to alert their health care professional immediately if they experience any of the above signs or symptoms.
  • If signs or symptoms of spinal hematoma are suspected, urgent diagnosis and treatment including spinal cord decompression should be initiated.
  • All anticoagulants carry the risk of causing epidural or spinal hematomas when used in conjunction with epidural/spinal anesthesia or spinal puncture.
  • Report adverse events involving enoxaparin to the FDA MedWatch program at www.fda.gov/medwatch.

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to this communication, including the complete data summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

And follow us on Twitter @FDA_Drug_Info for up to the minute important drug information. Know the moment it happens. 

 

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