FDA Rejects expanded use of New Blood Thinner

Johnson & Johnson's Xarelto (rivaroxaban) is an anticoagulant (blood thinner) that received Food and Drug Administration (FDA) approval last year to prevent blood clots in patients with atrial fibrillation (heart arrhythmia) and in those undergoing knee or hip replacement surgeries. J&J sought to expand the drug's approved uses to also treat acute coronary syndrome, but a federal advisory panel recommended against the request this week, saying the bleeding dangers related to the drug outweighed the potential benefits. Unlike other types of blood thinners, there is no known antidote for Xarelto if a patient experiences a bleeding emergency.

Standard treatment for acute coronary syndrome (obstruction of the coronary artery caused by a blood clot) currently involves a daily dose of aspirin along with the prescription medication Plavix. Members of the panel expressed concerns over adding a third drug to the regimen, particularly given the risk of bleeding associated with Xarelto. Dr. Steven E. Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic and a panel member, said that evidence of increased bleeding should not be lightly discarded. "These bleeds are not trivial," he warned, saying that if the bleeding occurred in the brain, it could cause irreversible damage, a fate he considered worse than death.

Despite the panel's recommendations, the FDA can still vote to expand the approved uses of the medication, even the advice of the experts. If approved, Xarelto sales would significantly increase; according to market research, 1.2 million patients are discharged from the hospital with acute coronary syndrome each year.

Blood thinners like Xarelto and Pradaxa (dabigtran) are extremely dangerous because, unlike Coumadin and Lovenox whose effects can be reversed with a shot of Vitamin K, there is no known antidote for these medications. If you have been injured by a dangerous blood thinner like Xarelto or Pradaxa, you may be entitled to compensation. Contact a drug injury attorney from Arnold & Itkin today for a free consultation regarding your case.