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Xarelto Expanded Use Denied Again by FDA

According to Reuters, the FDA once again declined to approve wider uses of the prescription drug Xarelto® (Rivaroxaban) late last month. Currently, the drug’s biggest approved use is to prevent blood clots and strokes in patients with an irregular heartbeat called atrial fibrillation. Recently, the drug’s co-marketers—Bayer AG and Johnson & Johnson—tried to expand the drug’s use. The companies sought approval from the U.S. Food and Drug Administration (FDA) to market Xarelto® for prevention of new heart attacks, strokes, and death, in patients with acute coronary syndrome (ACS), as well as for prevention of coronary events due to stent thrombosis.

Johnson & Johnson first sought approval for this expanded use in late 2011. The FDA rejected the application, citing missing data. The company retrieved some missing data but the FDA has once again declined to approve the drug. According to Reuters, the additional data did not alter the FDA’s view that the benefit of the drug was not shown to outweigh an increased risk of bleeding. The denial by the FDA comes after receiving over 600 reports on the drug’s adverse events, including serious and uncontrolled bleeding.

Xarelto® (Rivaroxaban) is a blood thinning medication alleged to cause serious and uncontrolled internal bleeding, particularly gastrointestinal bleeding, that could result in severe injuries, or even death. Xarelto® is part of a class of drugs called New Oral Anticoagulants (NOACs). This class of NOACs has been marketed as the next generation of blood-thinning drugs designed to replace warfarin – which has been on the United States market for more than 50 years.

If you or a loved one has suffered serious internal bleeding injuries after using Xarelto®, please contact the bad drug attorneys at Schlichter, Bogard & Denton, LLP toll-free at 1-800-873-5297 for your confidential and free consultation.


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