Bleeding in Spinal Column From Enoxaparin Use
Updated information will be added to label (November 6)
The 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 to delay the 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 (enoxaparin sodium injection) and generic enoxaparin products.
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 should identify the appropriate timing of enoxaparin dosing in relation to catheter placement or removal. To reduce the potential risk of bleeding, clinicians should 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 the 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 post-procedure 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 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. To address this safety concern, the 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.
Source: FDA; November 6, 2013.