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Agency's advisory panel to vote on whether Xarelto should beapproved for treating acute coronary syndrome. MONDAY, May 21 (HealthDay News) -- The new blood thinner Xareltoappears to lower the chances of potentially fatal blood clots inhigh-risk heart patients, a U.S. Food and Drug Administrationreview has found. The review came in briefing documents that were filed Monday inadvance of an FDA advisory panel meeting Wednesday, at which thepanel is to vote on whether to recommend approval of Xarelto fortreating people with acute coronary syndrome (a group of conditionsbrought on by sudden reduced blood flow to the heart). The FDA is not required to follow the advice of its expert panels,but the agency typically does. A final decision is expected by theend of June, according to the documents. Xarelto (rivaroxaban) is one of a new class of blood thinners thathave been developed to overcome some of the problems that existwith the standard treatment, warfarin (Coumadin), which requiresconstant dose monitoring. Warfarin's effectiveness also can bealtered by certain foods and other medications. Xarelto already isapproved for use by those with atrial fibrillation (irregularheartbeat) and by people who are having hip- or knee-replacementsurgery. In the FDA briefing documents, an agency reviewer recommendedapproving the drug for treatment of acute coronary syndrome, mostlybecause trial data showed there was a reduction in cardiovasculardeath, even though there was also an increased risk of potentiallyfatal bleeding. "However, what is not reflected in the sponsor's analysis are minorbleeding events," FDA reviewer Dr. Karen Hicks wrote in thebriefing documents. "While it is true that these bleeding eventstypically do not lead to death or irreversible harm, these eventsmay represent the biggest problem for both patients and health careproviders if rivaroxaban is approved." "While reductions in [cardiovascular] death still trump thesebleeding events, if rivaroxaban is approved, we should expect anumber of bleeding events that will require medical attention,"Hicks wrote. "Carefully selecting patients for rivaroxaban therapywill be necessary to mitigate these bleeding risks." In research presented at the American Stroke Association'sInternational Stroke Conference in New Orleans last February,Australian doctors followed more than 14,000 people who took eitherXarelto or warfarin for a median of two years. Of those patients,136 had bleeding in the brain. People who took Xarelto -- and suffered from the most common typeof atrial fibrillation and didn't have heart valve damage -- wereabout one-third less likely to experience bleeding in the brainthan those who took warfarin, the investigators found. More information The U.S. National Institute of Neurological Disorders and Strokehas more about stroke . SOURCES: May 21, 2012, briefing documents, U.S. Food and DrugAdministration; February 9, 2012, news release, American StrokeAssociation Copyright © 2012 HealthDay . All rights reserved. The e-commerce company in China offers quality products such as China N Female Connector , Dual Band Repeater, and more. For more , please visit Remote Control Jammer today!
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