FDA Warning: Lovenox Paralysis, Spinal Bleeding Side Effects

November 7, 2013 — The U.S. Food and Drug Administration (FDA) has issued a Drug Safety Communication to warn about the risk of paralysis caused by hematomas (spinal bleeding) in patients treated with Lovenox (enoxaparin), a powerful blood-thinner that is usually administered in hospitals.

The FDA is requiring new timing recommendations on the label for Lovenox to reduce the risk of hematoma and paralysis. They are recommending that healthcare professionals should:

“…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.”

Lovenox should be administered no sooner than 4 hours after a spinal catheter is removed. Placement or removal of a spinal catheter should be delayed for at least 12 hours after Lovenox is administered, and longer delays (24 hours) are appropriate for patients on high doses of Lovenox.

The label on Lovenox already carries warnings about the risk of paralysis from hematomas, but the FDA has continued to receive adverse event reports. Between July 1992 and January 2013, there were 170 cases of spinal or epidural hematoma associated with Lovenox, including 100 cases that were confirmed with an MRI, CT scan, or symptoms.

What is Lovenox?

Lovenox (enoxaparin) is an injectable blood-thinning drug that is used to prevent deep vein thrombosis (DVT), in which blood clots form in leg veins. It is a common problem in patients who are on bed rest after having a knee replacement, hip replacement, or abdominal surgery. Lovenox is often used in combination with another blood-thinner, warfarin, and sometimes aspirin, to prevent heart attacks and pulmonary embolisms.