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WASHINGTON (AP) -- A majority of Food and Drug Administrationpanelists voted against a new use for Johnson & Johnson's bloodthinner Xarelto to reduce life-threatening blood clots. The FDA's panel of experts voted 6-4 Wednesday against the new usefor the pill, saying too much information was missing from companystudies to accurately gauge the drug's benefit. One panel memberabstained. The FDA is not required to follow the group's advice, though itoften does. A final decision is expected by June 29. J&J already markets the pill for two patient groups: those withirregular heartbeat and those undergoing hip or knee replacementsurgery. The New Brunswick, N.J.-based company is now asking the FDA toapprove it as a preventive measure against life-threatening bloodclots in patients with acute coronary artery disease. That's acondition in which a narrowed blood vessel reduces flow to theheart muscle, increasing the risk of heart attack and othercatastrophic problems. The FDA's lead reviewer for the drug recommended approving theindication, based on a 15,500-patient J&J study showing Xareltosignificantly reduced a combination of fatal heart problems, strokeand heart attack. Panelists said the trial appeared successful, but they worried thatthe large number of patients who dropped out may have exaggeratedthe drug's effect. More than 2,400 patients, or 15.5 percent of thetotal study population, dropped out before completion. J&J arguedthat this drop-out rate is not unusual for a large, long-term drugstudy. Panelists also worried about bleeding side effects linked to thepill. Patients taking Xarelto were three times more likely to havemajor internal bleeding, compared with patients taking traditionalblood thinners like aspirin and Plavix. Xarelto would be used as anadd-on drug, in addition to those older blood thinners. Panelistssaid they were skeptical about creating a new standard wherepatients would take three drugs to prevent blood clots. Xarelto is part of a new group of blood thinners intended tosupplant the longtime standard treatment, warfarin, which is cheapbut requires frequent blood tests to get dosing right and caninteract with numerous foods and other medicines. J&J marketsXarelto in the U.S., and Bayer HealthCare sells it in otherregions. It was first approved in July. Other new blood thinners include Pradaxa from Boehringer Ingelheim,which was approved in October 2010. J&J shares fell 25 cents to close at $63.27. 2012 The Associated Press . All rights reserved. This material may not be published,broadcast, rewritten or redistributed. Learn more about our Privacy Policy and Terms of Use . The e-commerce company in China offers quality products such as Ball Closure Ring Manufacturer , Dermal Anchor Jewelry Manufacturer, and more. For more , please visit Lip Labret Jewelry today!
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