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FDA Issues Fresh Lovenox Warning

Filed November 8th, 2013 Laurie

The U.S. Food and Drug Administration (FDA) warned Wednesday that the anticoagulant drug Lovenox can cause spinal column bleeding and potential paralysis in patients fitted with a spinal catheter.

The agency said healthcare professionals should carefully consider timing when inserting or removing a spinal catheter in patients taking Lovenox, which is manufactured by Sanofi SA. Generic versions of the drug are sold under the name enoxaparin, according to Reuters.

Lovenox and enoxaparin already feature a warning that patients who have received or are scheduled to receive low molecular weight heparins such as Lovenox are at risk of developing an epidural or spinal bleed that can result in paralysis. The FDA said cases continue to be reported despite the warning, so the agency decided to update the warning to include information on timing, Reuters reported.

The agency said placement or removal of catheters should be delayed at least 12 hours after a patient is dosed with Lovenox. Such a procedure should be delayed at least 24 hours in patients receiving higher doses of the drug and should be given no sooner than four hours after a catheter is removed, according to Reuters.

The FDA said Sanofi reported 170 instances of spinal or epidural bleeds, known as hematomas, associated with Lovenox between July 20, 1992, and Jan. 31, 2013. Of those, the agency found that 100 cases contained a confirmed diagnosis, Reuters reported.

Lovenox is an injectable drug used to prevent blood clots in the leg veins in patients who are on bed rest or who are undergoing hip or knee replacement or abdominal surgery. It is often used in combination with warfarin, another anticoagulant, to treat blood clots in the leg, according to Reuters.

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