The U.S. Food and Drug Administration (FDA) issued a new warning on the use of the anticoagulant Lovenox (enoxaparin) in patients fitted with a spinal catheter because of the risk of spinal column bleeding and potential paralysis.
On Wednesday, the FDA advised healthcare professionals to carefully consider timing for inserting or removing a spinal catheter in patients taking Lovenox, made by Sanofi, or generic enoxaparin, Reuters reports. Catheters deliver painkillers or anesthetics directly into the spine.
Enoxaparin already carries a warning that patients are at risk of developing an epidural or spinal bleed that can result in paralysis. But cases continue to occur, the agency said, and, as a result, recommendations on dose timing will be added to the prescribing information. The FDA said placement or removal of the catheters should be delayed for at least 12 hours after a patient is dosed with enoxaparin, according to Reuters. A 24-hour delay is appropriate for patients receiving higher doses of the drug, and enoxaparin should be given no sooner than four hours after a catheter is removed.
Lovenox, an injectible drug, is used to prevent blood clots in the leg veins in patients on bed rest or who have had hip or knee replacement or abdominal surgery. It is often used with warfarin, another anticoagulant, to treat blood clots in the leg. The FDA said all anticoagulants carry the risk of spinal bleeding when used in conjunction with epidural anesthesia or spinal puncture.
The FDA says Sanofi reported 170 incidents of hematomas—spinal or epidural bleeds—associated with Lovenox between July 20, 1992, and January 31, 2013. The agency continues to evaluate the safety of other anticoagulants to determine if additional label changes are needed, according to Reuters. Health care professionals and consumers can report adverse reactions or quality problems with Lovenox through the MedWatch Adverse Event Reporting Program (www.fda.gov/medwatch/report.htm).