FDA approves Xarelto - a tablet to prevent DVT

Blood clots in the legs and lungs are a common and potentially deadly problem, especially after trauma, and hip or knee replacement surgery. Typically, we've used heparin, or more recently lovenox, injections to reduce the chance of these problems. But now, there's a tablet that does the same thing: Xarelto. You'll want to remember this name.

It was approved just this week, by the FDA, as a preventative measure against deep vein thrombosis (DVT), and pulmonary embolism (PE) following knee or hip replacement surgery. It's been approved in Europe and Canada for several years.

Xarelto is a pill taken once daily - how easy is that?! No blood tests are required. Patients having a knee replacement should take the medication for 12 days and patients undergoing a hip replacement procedure should take Xarelto for 35 days after surgery.

According to the studies, Xarelto was more effective than injections of Lovenox - our current standard treatment - in preventing DVT. In a study of more than 6,000 orthopedic patients, 9.7 percent of knee-replacement patients treated with Xarelto had a clot problem, compared with 18.8 percent of knee-replacement patients who received Lovenox. In a study involving hip replacement surgery, 1.1 percent of patients who received Xarelto had clots compared with 3.9 percent of those who received Lovenox.

So far, no one has done a study in plastic surgery patients, especially abdominoplasty. Under the current FDA labelling, that would be considered an "off-label" use. But if you had a family history of DVT, or you personally have had a DVT or PE in the past - this might be a new method to reduce your risk of having a blood clot after surgery. Interesting stuff!!

Xarelto: a new drug to reduce surgical risks

One of the most worrisome problems for surgeons is known as venous thromboembolism (VTE) - blood clots such as deep vein thrombosis and pulmonary embolism. These can occur after long operations, even in seemingly healthy people - and can be a life-threatening problem. In the past, we've used compression stockings, pneumatic sequential compression devices, or injectable blood thinners, like heparin and lovenox, to successfully reduce, but not completely eliminate, the risk of VTE's. However, these therapies have been awkward to use, especially for outpatient surgery.

Now, the FDA is looking at approving a new medication that may be very helpful with this problem. Called Xarelto, it's a once a day tablet. Technically speaking, it is classified as a direct Factor Xa inhibitor. According to the studies, it works as well or better than its injectable cousins (like lovenox) at preventing VTE. And unlike Coumadin, xarelto doesn't require frequent blood tests to get the dose right. As an oral medication, it would be easy to patients to continue on this therapy at home, while they are recovering from surgery.

Barring side effects, Xarelto could be a real breakthrough for patient safety. In the field of Plastic Surgery, the obvious application would be for abdominoplasty (tummy tucks), where the risk of VTE is significant. The optimal dosing schedule for plastic surgery patients hasn't yet been worked out.

The drug is approved in Europe. We're hoping for FDA approval soon.