FDA updates warning on Sanofi's blood thinner Lovenox
(Reuters) - The U.S. Food and Drug Administration issued a new warning on the use of the anticoagulant Lovenox in patients fitted with a spinal catheter because of the risk of spinal column bleeding and potential paralysis.
The FDA said on Wednesday that healthcare professionals should carefully consider timing when inserting or removing a spinal catheter in patients taking Lovenox, which is made by Sanofi SA, or its generic versions, which are sold under the name enoxaparin.
The catheters, fine plastic tubes, are used to deliver painkillers or anesthetics directly into the spine.
The drugs already contain 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. But cases continue to occur, the agency said. As a result, the recommendations on 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.
In patients receiving higher doses of the drug a delay of 24 hours would be appropriate, and the drug should be given no sooner 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 January 31, 2013, the FDA said. Of those, the agency found that 100 cases contained a confirmed diagnosis.
Lovenox is an injectible 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 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.
"We are continuing to evaluate the safety of other anticoagulants to determine if additional label changes are needed," the agency said.
(Reporting by Toni Clarke in Boston; Editing by Leslie Adler)