FDA Approves Xarelto for Irregular Heartbeat

Xarelto approved for stroke prevention in arrhythmia patients

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) U.S. Food and Drug Administration officials have given the green light to anti-clotting drug Xarelto (rivaroxaban) to reduce the risk of stroke in patients with a common heart arrhythmia called atrial fibrillation.

Rivaroxaban is the first oral direct factor Xa inhibitor that the agency has approved.

The ROCKET-AF trial had showed that rivaroxaban, produced by drugmaker Johnson & Johnson, was as effective as warfarin for preventing stroke and embolism in patients with atrial fibrillation.  Atrial fibrillation can lead to the formation of blood clots capable of traveling to the brain and causing a stroke by blocking blood flow.

"Ask your cardiologist which treatment is best for you."

One FDA reviewer had disagreed that the drug was proven to be as effective as warfarin, currently used as the standard treatment to prevent stroke in atrial fibrillation patients, and recommended against approval of the drug in September. The FDA's Cardiovascular and Renal Drugs Advisory Committee still recommended the drug for approval in a 9-2 vote.

Dr. Norman Stockbridge, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research, said that the approval gives physicians another treatment option for a condition that must be managed carefully.

Warfarin requires rigorous monitoring to ensure accurate dosing levels, and can present food and drug interaction problems.

Rivaroxaban was found to be both safe and effective in a clinical trial of more than 14,000 patients that compared it with warfarin. Like other anti-clotting drugs, rivaroxaban can cause bleeding that can lead to death in rare cases.

The risk of major bleeding when taking the medication is similar to warfarin, though it caused less bleeding into the brain, but more bleeding into the stomach and intestines.

The drug, marketed by Janssen Pharmaceuticals Inc., was approved by the FDA in July to reduce the risk of blood clots, deep vein thrombosis, and pulmonary embolism after knee or hip replacement surgery.

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Review Date: 
November 4, 2011
Last Updated:
November 6, 2011