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 Jan. 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.
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