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FDA Approves Xarelto to Prevent Stroke in People With Common Type of Abnormal Heart Rhythm
Date:11/4/2011

taken one time a day with the evening meal so that it will be completely absorbed.  

As with other anti-clotting drugs, Xarelto can cause bleeding that, rarely, can lead to death. Bleeding was the most common adverse event reported by patients treated with Xarelto in the major clinical trial for the prevention of stroke in non-valvular atrial fibrillation. In that trial, Xarelto's risk of major bleeding was similar to that of warfarin; however, it caused less bleeding into the brain and more bleeding into the stomach and intestines.

Xarelto has a boxed warning to make clear that people using the drug should not discontinue it before talking with their health care professional. Discontinuing the drug can increase the risk of stroke.

An FDA-required Medication Guide, which will be given to patients and caregivers when Xarelto is dispensed, describes the risks and adverse reactions people should be mindful of when using the drug.

Xarelto is marketed in the United States by Titusville, N.J.- based Janssen Pharmaceuticals Inc.

On July 1, 2011, the FDA approved Xarelto to reduce the risk of blood clots, deep vein thrombosis, and pulmonary embolism following knee or hip replacement surgery.

For information:
FDA: Approved Drugs: Questions and Answers

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov<
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SOURCE U.S. Food and Drug Administration
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