Low Molecular Weight Heparins: Drug Safety Communication – Recommendations to Decrease Risk of Spina
Friday, November 22, 2013
Low Molecular Weight Heparins: Drug Safety Communication – Recommendations to Decrease Risk of Spinal Column Bleeding and Paralysis
ISSUE: The U.S.
Food and Drug Administration (FDA) is recommending that health care
professionals 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 and generic enoxaparin
products and similar products.
Epidural or spinal hematomas are a known risk of 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
(see Data Summary at http://www.fda.gov/Drugs/DrugSafety/ucm373595.htm).
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
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.
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:
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
post-procedure dose of enoxaparin should usually be given no sooner than 4
hours after catheter removal.
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.
Read the MedWatch Drug Safety Communication,
including a link to the full Drug Safety Communication here.
Source: U.S. Food and Drug Administration (FDA) (Accessed: 11/11/2013)