U.S. FDA updates warning on Sanofi's blood thinner Lovenox

Reuters

Nov 6 (Reuters) - The U.S. Food and Drug Administrationissued a new warning on the use of the anticoagulant Lovenox inpatients fitted with a spinal catheter because of the risk ofspinal column bleeding and potential paralysis.

The FDA said on Wednesday that healthcare professionalsshould carefully consider timing when inserting or removing aspinal catheter in patients taking Lovenox, which is made bySanofi SA, or its generic versions, which are soldunder the name enoxaparin.

The catheters, fine plastic tubes, are used to deliverpainkillers or anesthetics directly into the spine.

The drugs already contain a warning that patients who havereceived or are scheduled to receive low molecular weightheparins such as Lovenox are at risk of developing an epiduralor spinal bleed that can result in paralysis. But cases continueto occur, the agency said. As a result, the recommendations ontiming will be added to the prescribing information.

The FDA said placement or removal of the catheters should bedelayed for at least 12 hours after a patient is dosed withenoxaparin.

In patients receiving higher doses of the drug a delay of 24hours would be appropriate, and the drug should be given nosooner than four hours after a catheter is removed.

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

Lovenox is an injectible drug used to prevent blood clots inthe leg veins in patients who are on bed rest or who areundergoing hip or knee replacement or abdominal surgery. It isoften used with warfarin, another anticoagulant, to treat bloodclots in the leg.

The FDA said all anticoagulants carry the risk of spinalbleeding when used in conjunction with epidural anesthesia orspinal puncture.

"We are continuing to evaluate the safety of otheranticoagulants to determine if additional label changes areneeded," the agency said.

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