FDA Approves Another Anticoagulant


Earlier this month, the FDA approved Xarelto (rivaroxaban) to cut the risk of blood clots, DVT, and pulmonary embolism after knee and hip replacement surgery. According to one hospitalist, the drug approval represents another way to prevent blood clots on an outpatient basis.

The drug is a pill that is taken once a day. Those having knee replacements should take the medication for 12 days, and those having hip replacements should take it for 35 days, according to FDA guidelines.

"I think that it has the potential of being a game-changer," says Robert Pendleton, MD, codirector of the hospitalist program and medical director of the University Healthcare Thrombosis Service at the University of Utah Medical Center in Salt Lake City. "It definitely could turn out to be a blockbuster drug."

In a statement, Paul Chang, MD, vice president of medical affairs in internal medicine at Janssen Pharmaceuticals Inc., said, "Shorter hospital stays following hip and knee replacement surgeries have made the prevention of venous blood clots an outpatient issue, and Xarelto provides a safe and effective oral treatment option that can be easily transitioned from use in hospital to home."

The approval is the latest challenge to warfarin. It comes on the heels of the approval of Pradaxa (dabigatran) for stroke prevention in nonvalvular atrial fibrillation patients. (Updated July 21). Xarelto, however, is the only new oral anticoagulant approved for its indication.

Dr. Pendleton says the advantage of Xarelto is that it only has to be taken once a day. He said the full potential lies in the "high likelihood of subsequent indications" for the drug.

Still, this is a new drug and care has to be taken, he says.

"If it's not used appropriately in the proper patient with proper attention to renal function and drug-drug interaction," he adds, "a very promising drug could have difficulty."

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