Rivaroxaban Approved by FDA to Prevent Strokes in AF Patients

The FDA recently approved another oral anticoagulant medication to help prevent strokes in patients with atrial fibrillation (AF). On November 4, the FDA announced its approval of rivaroxaban (Xarelto) for use in AF patients after a recent review of the drug.

In its statements, the FDA said, “Xarelto has a boxed warning to make clear that people using the drug should not discontinue it before talking with their healthcare professional. Discontinuing the drug can increase the risk of stroke.”

A study published in the New England Journal of Medicine showed that the new anticoagulant Xarelto, which is a factor Xa inhibitor, was effective at helping to prevent strokes as well as non-central-nervous-system (CNS) embolisms. As recently as September, Heartwire reported that the Cardiovascular and Renal Drugs Advisory Committee recommended the drug for approval in a 9 to 2 vote.

The most difficult thing that Xarelto had to deal with from the FDA advisory committee was how the drug compared to the popular Warfarin. Warfarin has been proven to treat AF patients at “optimal international normalized ratio (INR) of 57.8 percent of the time in therapeutic range (TTR), which was lower than in other trials with Warfarin, including the Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) trial with dabigatran etexilate (Pradaxa, Boehringer Ingelheim),” according to an article posted on Medscape Today.

This was enough cause for some panelists to remain unsure about the efficacy of Xarelto, while others were worried about the dose of Xarelto that was tested and “the risk of adverse clinical events when patients are transitioned off rivaroxaban.” After 28 days of using the rivaroxaban had stopped, the ROCKET-AF patients were then given a different anticoagulant medication. They then saw an increase of stroke risks, which is why the investigators believed that Xarelto has a short half-life. This was why so many panelists didn’t believe that the Xarelto was better than Warfarin, and recommended the drug only be used as a third line of defense.

AF patients can’t seem to catch a break in their medication options. Multaq, made by Sanofi-Aventis, has been demoted down to a last resort since it has been found to cause liver failure and even worsen AF patient’s heart conditions. Xarelto may not fare any better in preventing strokes. If you or a loved one have suffered from liver failure after taking Multaq, contact attorney Greg Jones today for a free consultation. I am experienced at fighting Multaq lawsuits and may be able to help you recover money for your injuries.

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