However, new lawsuits continue to emerge, and in 2014 alone 3,331 incidents associated with Xarelto bleeding problems were reported. These two cases alone represent more than 2,000 lawsuits.
Since December of 2014, Xarelto lawsuits against Bayer and Johnson & Johnson have largely been consolidated in two courts, a Multi District Litigation (MDL) court in Louisiana and a mass tort litigation court in Philadelphia. Thousands of lawsuits have emerged alleging that Xarelto was improperly marketed as a safer alternative to other anticoagulant drugs, marketed without an antidote and has led to many instances of massive uncontrollable bleeding events. The new suits allege that the drug’s manufacturers misrepresented its benefits, risks and dangers and that the drug has caused uncontrollable bleeding episodes that have led to multiple patient deaths.ĭeveloped jointly by Johnson & Johnson’s Janssen Pharmaceuticals subsidiary and Bayer Healthcare, Xarelto was approved by the FDA to aid in preventing strokes in 2011. New lawsuits are emerging in the ongoing Xarelto saga. The bad news for the patients already using Eliquis is that unfortunately the FDA does not have specific deadlines for approving this drug and there is no way to tell when it will be available or approved for use.New Xarelto Lawsuits Emerge as Pradaxa Antidote Is Approved For this possible antidote to Eliquis, there is still about 7 steps remaining before the FDA will consider this drug safe and/or approve for the market. According to the American Heart Association Scientific Sessions, the study shows that andecanet alfa safely and effectively reversed the anticoagulant effects of Eliquis among older patients.įDA has several steps before approving/denying a drug application or completing a response letter. Previous reports have indicated that andexanet alfa significantly reverse anti-Factor Xa activity and the inhibition of thrombin generation among healthy participants who were anticoagulated with Eliquis, Xarelto or Lovenox. Andexanet alfa, a modified, recombinant human Factor Xa inhibitor molecule, is a universal antidote for Factor Xa inhibitors.
XARELTO ANTIDOTE TRIAL
Several studies that have been published this month show results of ANNEXA-A, a phase 3, randomized, double blind, placebo-controlled trial that assessed investigational use of andexanet alfa (manufactured by Portola Pharmaceuticals) for the reversal of Eliquis –induced anticoagulation in older patients, ranging from 50 to 75 years of age. Unlike the anticoagulant Warfarin, which has an approved antidote, or reversal agent Eliquis (and Xarelto) lack an approved antidote or reversal agent. Eliquis, just like Xarelto, can be prescribed to patients who just had hip or knee replacement surgery to reduce the risk of blood clots forming in their legs or lungs. Eliquis is also prescribed to treat blood clots in the veins of your legs (known as Deep Vein Thrombosis, DVT) or lungs (known as Pulmonary Embolism, PE), and to reduce the risk of these clots occurring again. This drug was introduced in 2012 as another new generation of blood thinners, known as direct thrombin inhibitors.Įliquis, like Xarelto, is a prescription medication used to reduce the risk of stroke and blood clots in people who have atrial fibrillation, a type of irregular heartbeat which is not caused by a heart valve problem. Eliquis is jointly manufactured by Pfizer and Bristol-Myers Squibb (BMS). Eliquis, like Xarelto, lacks an approved reversal agent that could allow doctors to stop the bleeding or hemorrhaging that may develop in some users. Eliquis (apixaban) is the third drug that has been approved in the new class of anticoagulants, which supports concern of the risk of fatal bleeding while taking it.
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