FDA Panel Votes Against Johnson & Johnson Blood Thinner
A majority of Food and Drug Administration panelists have voted against a new use for Johnson & Johnson’s blood thinner Xarelto to reduce life-threatening blood clots.
The FDA’s panel of experts voted 6-4 against the new use for the pill, saying too much information was missing from company studies to gauge the drug’s benefit. One panel member abstained.
J&J already markets the pill to treat irregular heartbeat and patients undergoing hip or knee replacement surgery.
Now J&J wants the FDA to approve it as a preventive measure against life-threatening blood clots in patients with acute coronary artery disease.
While J&J’s study appeared to show the drug reduced fatal heart problems, panelists were concerned by the large number of patients who dropped out of the study.
(Copyright 2012 by The Associated Press. All Rights Reserved.)