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
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.