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WASHINGTON, DC—The Food & Drug Administration’s advisors voted 6-4 against expanding the use of the Johnson & Johnson’s drug Xarelto.
The blood thinner has already been approved in the U.S. to reduce the risk of blood clots in patients who have undergone knee or hip replacement surgery and prevent strokes in people with atrial fibrillation not caused by a heart valve problem, according a report on NJ.com.
J&J’s sudidiary Janssen Research and Development wanted to expand the use of the drug to treat patients with acute coronary syndrome.
However, the advisory panel was concerned about adding a third drug to two other drugs already used to treat the heart problem, according to a report in the Wall Street Journal.
Steven Nissen, the chairman of the cardiovascular department at the Cleveland Clinic, was one of those who voted against Xarelto.
He claimed that there is a lack of information known about bleeding risks, which include a type of stroke caused by bleeding in the brain, and more information would be needed before expanding use of the drug.
Paul Burton, the cardiovascular franchise medical leader at Janssen Research & Development LLC, a unit of Johnson & Johnson responded to the panel’s descision: “We appreciate the thoroughness of the committee’s review, and will ensure the questions raised today are addressed with the FDA”.