FDA Approves Expanded Use of XareltoLast Updated: November 05, 2012.
MONDAY, Nov. 5 (HealthDay News) -- Approval of the anti-clotting drug Xarelto (rivaroxaban) has been expanded by the U.S. Food and Drug Administration to include treating deep vein thrombosis (DVT) or pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE following initial treatment.
Xarelto was approved last year to treat clots stemming from knee or hip replacement and to lessen the risk of stroke in people with non-valvular atrial fibrillation.
The drug's newest approvals were given based on clinical studies involving 9,478 people, the FDA said in a news release. As with other anti-clotting drugs, bleeding is the most common side effect.
Xarelto is produced by Janssen Pharmaceuticals, based in Raritan, N.J.
The FDA has more about this approval.