New FDA Recommendations to Reduce Bleeding Risk with Anticoagulants
The FDA is recommending that healthcare professionals carefully time the spinal catheter placement and removal in patients taking anticoagulants (eg, enoxaparin), and delay dosing of anticoagulants for some time after catheter removal to decrease the risk of spinal column bleeding and subsequent paralysis after spinal injections which include epidural procedures and lumbar punctures.
This is in efforts to reduce the risk of epidural or spinal hematomas associated with low molecular weight heparin products.
These new timing recommendations are being added to the labels of anticoagulant drugs, known as low molecular weight heparins. These drugs include brand Lovenox (Sanofi-Aventis), generic enoxaparin products, and other similar products.
The risk of epidural or spinal hematomas are already described in the Boxed Warnings and the Warnings/Precautions sections of the labels for Lovenox and generic enoxaparin products. However, due to its continued incidence, the FDA worked with Sanofi-Aventis to further evaluate the risk and to update the label with these additional timing recommendations. This safety update affects all low molecular weight heparin-type products.
It is recommended that healthcare professionals identify the appropriate timing of enoxaparin dosing in relation to catheter placement or removal. Both the dose and elimination ½-life of the anticoagulant should be considered:
- For enoxaparin, placement or removal of a spinal catheter should be delayed for at least 12 hours after administration of prophylactic doses (eg, DVT prevention)
- Longer delays (24 hours) are appropriate to consider for patients receiving higher therapeutic doses of enoxaparin (1mg/kg twice daily or 1.5mg/kg once daily)
- A post-procedure dose of enoxaparin should usually be given no sooner than 4 hours after catheter removal
Overall, a benefit-risk assessment should consider both the risk for thrombosis and bleeding in regards to the procedure and patient risk factors.
For more information call (888) 463-6332 or visit the FDA Safety Alert page.