Product News and Recalls

Xarelto Reversal Agent Succeeds in Late-Stage Trial

xarelto reversal agent closer to approvalReuters reports that andexanet alfa, a drug developed by Portola Pharmaceuticals to reverse the bleeding side effects of new oral anticoagulants like Xarelto, has proven successful in a late-stage clinical trial. Portola hopes the new data will help earn the antidote approval from the U.S. Food and Drug Administration.

Xarelto is a relatively new blood thinner that has made strides in the pharmaceutical industry since its introduction in 2011. The drug’s manufacturers, Janssen Pharmaceuticals and Bayer HealthCare, have marketed Xarelto as a safer and more effective alternative to older anticoagulants like warfarin. But several years of accumulated adverse event reports suggest that new blood thinners like Xarelto still pose a risk of severe bleeding. Moreover, patients have been quick to point out there is no approved remedy for the drug’s side effects. This means bleeding cannot reliably be stopped in the event of emergency surgery. The effects of older anticoagulants, such as warfarin, can be reversed with Vitamin K treatment.

Plaintiffs who have filed Xarelto lawsuits claim that Janssen and Bayer did not do enough to warn patients and doctors of the bleeding risk Xarelto poses. Late last year, the U.S. Judicial Panel on Multidistrict Litigation consolidated all pending federal Xarelto bleeding lawsuits for coordinated pretrial proceedings. While just 100 Xarelto lawsuits were included at the outset, the MDL now contains over 2,000 cases, and that number is expected to increase even more by the time trials begin in early 2017.

With andexanet alfa, Portola hopes to fill the much-needed role of Xarelto reversal agent. Researchers who conducted the late-stage trial report that the drug successfully reversed Xarelto’s anticoagulant effect within minutes and without any observed side effects. Compared with a placebo, andexanet alfa reduced the drug’s blood thinning effects by 97 percent for one to two hours after administration.

Tell your doctor about any health concerns you may have. If you or a loved one suffered from severe bleeding after taking Xarelto, contact the lawyers at Lopez McHugh today to receive a free legal consultation. You may be entitled to compensation through a Xarelto bleeding lawsuit.