Xarelto's Approval Expanded
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.
DVT occurs when a blood clot forms in a vein deep in the body. If a clot breaks away and travels to an artery in the lungs, it becomes a potentially deadly condition called a pulmonary embolism.
Xarelto was approved last year to treat clots stemming from knee or hip replacement and to lessen the risk of stroke in people with a form of abnormal heart rhythm called 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.Related Articles
- Some Painkillers Tied to Bleeding Risk in Those With Abnormal Heartbeat
November 17, 2014
- Two Generic Versions of ADHD Drug Not as Effective: FDA
November 14, 2014
Learn More About Sharp
Sharp HealthCare is San Diego's health care leader with seven hospitals, two medical groups and a health plan. Learn more about our San Diego hospitals, choose a Sharp-affiliated San Diego doctor or browse our comprehensive medical services.
Copyright ©2012 HealthDay. All rights reserved.