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FDA Warning: Lovenox Paralysis, Spinal Bleeding Side Effects

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November 7, 2013 — Healthcare professionals should delay administering Lovenox (enoxaparin), a powerful blood-thinner, to patients who have had spinal injections to reduce the risk of spinal bleeding (hematomas), which can cause paralysis.

The U.S. Food and Drug Administration (FDA) has published a Drug Safety Communication with new guidelines for timing doses of Lovenox to reduce the risk of hematoma and paralysis.

Although the label on Lovenox already warned about these risks, the FDA received 170 reports of spinal bleeding between July 1992 and January 2013. Of these, 100 cases were confirmed with a CT scan, MRI, or symptoms.

The FDA has added stronger warnings to clarify recommendations:

“Placement or removal of a spinal catheter should be delayed for at least 12 hours after administration of [Lovenox]. 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.”

What is Lovenox?

Lovenox (enoxaparin) is a blood-thinning medication that is primarily administered by injection to patients in hospitals. It is used to prevent blood clots from forming in the legs (also called “deep vein thrombosis” or DVT), which can cause heart attacks, stroke, or pulmonary embolism. It is mostly given to patients who have had abdominal surgery, a knee replacement, or a hip replacement. Lovenox is often administered in combination with warfarin or aspirin.

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