The U.S. Food and Drug Administration just issued a revised warning over Sanofi SA’s anticoagulant, Lovenox (enoxaparin).
The warning involves patients taking Lovenox who are implanted with a spinal catheter over risks of spinal column bleeding and potential paralysis, according to a recent Reuters report. The agency announced that health care professionals should seriously consider the timing of inserting or removing spinal catheters in their patients who are taking Lovenox.
The Lovenox brand is manufactured by drug maker, Sanofi SA. Generic versions—enoxaparin—are also included in the warning. Catheters are delicate plastic tubes that deliver medicines such as painkillers and anesthetics directly into patients’ spines, Reuters explained.
Lovenox and its generic versions currently contain a warning that states that patients who have received, or who will be receiving, Lovenox and other low molecular weight heparin medications are at increased risk for developing an epidural or spinal bleed, which can lead to paralysis, according to Reuters. The FDA states that reports of these types of injuries continue to be received. Because of this, timing recommendations will be included in the prescribing information for Lovenox and its generic versions.
The FDA suggests that both catheter placement and removal should be delayed for no less than 12 hours following patient dosage with Lovenox (enoxaparin), Reuters reported. For patients on higher Lovenox doses, a 24-hour delay would be appropriate, the agency states. The drug should not be given to patients any sooner than four hours following catheter removal.
To date, Sanofi has reported 170 cases of spinal or epidural bleeds, which are known as hematomas, and which were tied to Lovenox. The reports were received between July 20, 1992 and January 31, 2013, according to the FDA. Of the 170 cases, the agency indicated that a confirmed diagnosis was involved in most—100—of the cases, wrote Reuters.
Lovenox is an injectable medication that is used in the prevention of blood clots in the leg veins of patients who are either on bed rest or who are undergoing hip or knee replacement surgery or abdominal surgery, according to Reuters. Lovenox is also often prescribed in conjunction with warfarin, another blood thinner, in the treatment of blood clots in the legs.
According to the agency, all anticoagulants carry increased risks for spinal bleeding when used along with epidural anesthesia or spinal puncture. Reuters reported. “We are continuing to evaluate the safety of other anticoagulants to determine if additional label changes are needed,” the agency said.
