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J&J drug reduced fatal heart attacks, but FDA questions missing data from company study
WASHINGTON (AP) ' The Food and Drug Administration says a blood thinner from Johnson & Johnson appears to reduce life-threatening blood clots in high-risk patients, although it also increases the risk of internal bleeding.
The FDA posted its review of J&J's Xarelto for the new use ahead of a public meeting Wednesday where medical experts will assess its safety and effectiveness.
J&J already markets Xarelto for two indications: irregular heartbeat and for patients undergoing hip or knee replacement surgery.
J&J is now asking the FDA to approve it as a treatment for life-threatening blood clots in patients with narrowed blood vessels, who are at increased risk for heart attack, stroke and other catastrophic problems.
FDA reviewers say Xarelto appears to reduce those problems, though J&J's study was missing several key data points.