In one case, an Indiana plaintiff was awarded nearly $28 million, but the verdict was later overturned.

Three of these cases have gone to trial, ending in verdicts for the defendant. Over 3,000 of those cases were fatal, according to the Institute for Safe Medication Practices (ISMP).Ĭurrently, there are over 20,000 lawsuits pending in federal court against Bayer over injuries attributed to Xarelto. In 2016, there were approximately 22,000 adverse events attributed to Xarelto and other Factor Xa inhibitors. The first Factor Xa inhibitor to be made available in pharmacies, AndexXa can potentially save thousands of patients taking Xarelto and Eliquis from fatal hemorrhaging. Approval was again delayed this past February when the FDA required additional time to review information from the manufacturer.Īpproval was finally granted in May. Shortly thereafter, an editorial was published in the New England Journal of Medicine, questioning the safety and efficacy of the antidote. The company first sought FDA approval in August 2016, but the application was denied over concerns about the manufacturing process. AndexXa has been in development since 2014. The drug has been developed by Portola Pharmaceuticals, a small biotech firm located near San Francisco.

The problem is that these medications have done their job too well: by disabling the blood's clotting mechanism, it has caused patients to experience uncontrollable hemorrhaging, even from slight bumps.ĪndexXa ( andexanet alfa) is a universal antidote, or reversal agent for these medications. The companies producing these drugs have claimed they are more effective and have far fewer interactions than warfarin, the standard first-line treatment for blood clotting for the past six decades. These medications include rivaroxaban, manufactured and marketed by Bayer and Janssen under the brand name Xarelto, and apixaban, a product of Pfizer and Bristol-Myers Squibb, sold as Eliquis. Food and Drug Administration has finally approved the first antidote for Factor Xa anticoagulants, also known as “new generation” blood thinners or “Novel Oral Anti-Coagulants” (NOACs).

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