Lovenox Paralysis, Spinal Bleeding Problems Result in FDA Warning

According to a new warning issued by federal health regulators, side effects of the blood thinner Lovenox could increase the risk of spinal bleeding and even paralysis when patients undergo spinal procedures.  

In a drug safety communication issued November 6, the FDA indicated that health care professionals should be careful when adding or removing spinal catheters to patients who have taken Lovenox.

The FDA also warns that these and other spinal procedures, particularly injections like epidural procedures and lumbar punctures, have to be carefully timed to avoid serious injury to patients using the drug.

Lovenox (enoxaparin) is an injection drug used to prevent deep vein thrombosis among patients on bed rest or who have recently undergone a hip replacement, knee replacement or abdominal surgery. It is often used with Coumadin (warfarin) to treat blood clots in the leg, and is also used with aspirin in the aftermath of a heart attack to prevent further problems. The brand name version is a Sanofi-Aventis drug, but it is also available in generic form.

The FDA announced that Sanofi-Aventis has reported 170 cases of spinal or epidural hematoma linked to Lovenox over the last 21 years. Reviewing the report, the FDA found that 100 cases resulted in a confirmed spinal or epidural hematoma diagnosis.

While spinal and epidural hematomas, which can cause paralysis and dangerous spinal bleeding, were already linked to Lovenox, the FDA has called for additional safety precautions because reports of serious adverse events have continued to come to the agency’s attention. The FDA and Sanofi-Aventis are working together to update the drug’s Warnings and Precautions label section.

“Health care professionals and institutions involved in performing spinal/epidural anesthesia or spinal punctures should determine, as part of a preprocedure checklist, whether a patient is receiving anticoagulants and identify the appropriate timing of enoxaparin dosing in relation to catheter placement or removal,” the FDA advises. ” To reduce the potential risk of bleeding, consider both the dose and the elimination half-life of the anticoagulant.”

The FDA recommends that doctors delay placement or removal of a spinal catheter for at least 12 hours after giving a patient a Lovenox dose to prevent deep vein thrombosis. For patients being given higher therapeutic doses of Lovenox, 24 hours is an appropriate wait time.

The agency also recommends that doctors should wait four hours minimum to give patients a postprocedure dose of Lovenox following catheter removal. The FDA warns that in all cases, a benefit-risk assessment should look at both the risk of blood clots and the risk of bleeding.