Nov 6 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
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
"We are continuing to evaluate the safety of other
anticoagulants to determine if additional label changes are
needed," the agency said.