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CME/CE

FDA Safety Alert: Reduce Operative Bleeding Risk in Patients Taking LMWHs

  • Authors: News Author: Susan Jeffrey
    CME Author: Laurie Barclay, MD
  • CME/CE Released: 11/26/2013
  • THIS ACTIVITY HAS EXPIRED
  • Valid for credit through: 11/26/2014
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Target Audience and Goal Statement

This article is intended for primary care clinicians, intensivists, neurosurgeons, orthopaedists, neurologists, anesthesiologists, and other specialists who care for patients undergoing spinal intervention.

The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care.

Upon completion of this activity, participants will be able to:

  1. Describe a new FDA drug safety advisory regarding use of low-molecular-weight heparins in patients undergoing spinal intervention.
  2. Discuss drug manufacturer data underlying the new FDA drug safety advisory regarding use of low-molecular-weight heparins in patients undergoing spinal intervention.
  3. List new FDA recommendations aimed at reducing the risk of spinal column bleeding after spinal intervention, including epidural procedures and lumbar puncture, in patients taking low-molecular-weight heparins.


Disclosures

As an organization accredited by the ACCME, Medscape, LLC, requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest. The ACCME defines "relevant financial relationships" as financial relationships in any amount, occurring within the past 12 months, including financial relationships of a spouse or life partner, that could create a conflict of interest.

Medscape, LLC, encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.


Author(s)

  • Susan Jeffrey

    Susan Jeffrey is the news editor for Medscape Neurology & Neurosurgery. Susan has been writing principally for physician audiences for nearly 20 years. Most recently, she was news editor for thekidney.org and also wrote for theheart.org; both of these Web sites have been acquired by WebMD. Prior to that, she spent 10 years covering neurology topics for a Canadian newspaper for physicians. She can be contacted at [email protected]

    Disclosures

    Disclosure: Susan Jeffrey has disclosed no relevant financial relationships.

Editor(s)

  • Amy Nadel

    Disclosures

    Disclosure: Amy Nadel has disclosed no relevant financial relationships.

CME Author(s)

  • Laurie Barclay, MD

    Freelance writer and reviewer, Medscape, LLC

    Disclosures

    Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships.

CME Reviewer(s)

  • Yullee C. Chui

    Program Manager, Medscape, LLC

    Disclosures

    Disclosure: Yullee C. Chui has disclosed no relevant financial relationships.


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CME/CE

FDA Safety Alert: Reduce Operative Bleeding Risk in Patients Taking LMWHs

Authors: News Author: Susan Jeffrey CME Author: Laurie Barclay, MDFaculty and Disclosures
THIS ACTIVITY HAS EXPIRED

CME/CE Released: 11/26/2013

Valid for credit through: 11/26/2014

processing....

Clinical Context

Enoxaparin is an injectable low-molecular-weight heparin (LMWH), used as an anticoagulant to prevent thrombosis of the leg veins in patients who are on bed rest or who are undergoing hip replacement, knee replacement, or abdominal surgery. To treat deep vein thrombosis in the leg, the drug is often used with warfarin. It is also used in combination with aspirin to reduce complications from myocardial infarction.

Epidural or spinal anesthesia, spinal puncture, or epidural injection for pain in patients receiving an anticoagulant such as enoxaparin is associated with a risk for epidural or spinal hematoma. Such a risk could result in paralysis and/or other serious complications.

Synopsis and Perspective

The US Food and Drug Administration (FDA) released a drug safety advisory with recommendations aimed at reducing the risk of spinal column bleeding after spinal intervention, including epidural procedures and lumbar puncture, in patients taking LMWHs.

The agency is recommending that "health care professionals carefully consider the timing of spinal catheter placement and removal, and delay dosing of anticoagulant medications for some time interval after catheter removal," to decrease the risk of spinal bleeding and subsequent paralysis in these patients.

"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 and generic enoxaparin products and similar products," the FDA said in the safety announcement.

Epidural or spinal hematomas are a known risk associated with enoxaparin in the setting of spinal procedures and are already included in a Boxed Warning and the Warning and Precautions sections of the labels for enoxaparin and generic enoxaparin products. "However these serious adverse events continue to occur," the FDA notes.

The drug manufacturer submitted 170 cases of spinal or epidural hematoma associated with enoxaparin thromboprophylaxis and neuraxial spinal or epidural anesthesia or spinal puncture reported between July 20, 1992, preceding FDA approval of Lovenox on March 29, 1993, and January 31, 2013.

"FDA reviewed these reports and found that 100 cases contained a confirmed diagnosis of spinal or epidural hematoma (by computed tomography [CT], magnetic resonance imaging [MRI], clinical symptoms/signs or surgical findings) or clear mention of spinal or epidural anesthesia, spinal puncture, or epidural anesthesia."

To address this safety concern, they note, the FDA worked with the drug manufacturer, "to further evaluate this risk and to update the Warnings and Precautions section of the Lovenox label with these additional time recommendations. The labels for generic enoxaparin products will be revised accordingly, as will those of other low-molecular-weight heparin-type products."

All anticoagulants carry this 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," the announcement notes.

Specifically, the FDA recommends that "health care professionals and institutions involved in performing spinal/epidural anesthesia or spinal punctures should determine, as part of a pre-procedure 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."

Clinical Implications

  • A new FDA drug safety advisory regarding use of LMWHs in patients undergoing spinal intervention, including epidural procedures and lumbar puncture, offers new recommendations intended to reduce the risk of spinal column bleeding in these patients. Despite a Boxed Warning on the labels for enoxaparin and generic enoxaparin products (as well as information in the Warning and Precautions sections) concerning the risk for epidural or spinal hematomas, these adverse events continue to occur.
  • The drug manufacturer submitted for FDA review 170 cases of spinal or epidural hematoma associated with enoxaparin thromboprophylaxis and neuraxial spinal or epidural anesthesia or spinal puncture. Of these, 100 cases had a confirmed diagnosis of spinal or epidural hematoma by CT; MRI; clinical symptoms/signs or surgical findings; or clear mention of spinal or epidural anesthesia, spinal puncture, or epidural anesthesia.
  • The FDA recommends that clinicians and institutions involved in spinal or epidural anesthesia or spinal punctures use a preprocedure checklist to record use of anticoagulants and to identify the appropriate timing of enoxaparin dosing relative to catheter placement or removal. To lower the potential risk of bleeding, both the dose and the elimination half-life of the anticoagulant should be considered.

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