![]() The makers of both drugs are currently in lawsuits for failing to warn about the lack of an antidote to the drugs. It is important to understand that Xarelto and Pradaxa (another anticoagulant medication) do not have an antidote at this time for the serious issues of uncontrolled bleeding which may result in some, if not many, of the above listed serious injuries. The agency also made serious note that the most common risks were bleeding complications. Pour prévenir les accidents thromboemboliques chez les patients atteints de fibrillation auriculaire, il n’est pas démontré que l’apixaban soit plus efficace qu’un traitement par warfarine bien conduit en cas de risque thrombotique important, ou que par warfarine ou aspirine, en cas de risque thrombotique modéré. Specifically, the FDA warned that including the benefits information without including any of the risks section (or emphasis there on of the possible risks) made it appear as though there were no significant risks associated with the drug. The FDA issued a warning letter to the maker of Xarelto in 2013, noting that a print advertisement for Xarelto made a misleading claim by minimizing the risks associated with the drug. Importantly, patients who were not part of the settlement can still file lawsuits against Bayer Healthcare or Janssen Pharmaceuticals.The lawsuit also includes allegations that the defendants did not properly warn patients about the lack of an antidote to Xarelto, which therefore increases the risk of uncontrolled bleeding. "It may have taken more than four years and six separate trials but litigation like this is an important way for consumers to have a voice in matters of drug safety." "We're pleased that these drug companies have agreed to allow all these Xarelto patients to move their claims forward after years of seeking justice," said Brian Barr co-lead counsel of the Plaintiffs' Steering Committee for multidistrict litigation. The 2019 guideline from the Anticoagulation Forum provides clear instructions on how to use 2 agents for reversing the effects of direct oral anticoagulants (DOACs): idarucizumab for dabigatran-associated bleeding and andexanet alfa for bleeding associated with rivaroxaban and apixaban. These cases had been combined as part of multidistrict litigation (MDL). Portola Pharmaceuticals announced that the FDA approved its Prior Approval Supplement for the second generation of andexanet alfa, allowing for its broad commercial launch in the U.S. Nevertheless, on March 25, 2019, Bayer Healthcare and Janssen Pharmaceuticals settled virtually all of the pending Xarelto lawsuits for $775 million.Īt the time, there were roughly 23,866 lawsuits pending in The United States District Court for the Eastern District of Louisiana alone. ![]() ![]() Ultimately, the jury sided with the defendant-Janssen Pharmaceuticals. The defendant’s attorney argued that Sharyn had a host of medical problems and that her uncontrolled high blood pressure was the cause of her brain hemorrhage. ![]() In the emergency room, the neurosurgeon delayed operating on Sharyn’s skull because he didn’t know how much Xarelto was circulating in her body.Īt trial, the plaintiff’s attorney argued that Sharyn died because she took Xarelto and because the manufacturer failed to include necessary safety labels on the medication. ![]() The lawsuit also alleged that Janssen Pharmaceuticals failed to state on the label that a prothrombin time (PT) test would reveal how much Xarelto was in the patient’s blood. There is currently no reversal agent for Xareltos uncontrollable bleeding. The lawsuit alleged that Xarelto was unreasonably dangerous. Sharyn’s husband, Joseph Orr, filed a wrongful death lawsuit against Janssen Pharmaceuticals. Sharyn Orr, an academic advisor at Tulane University for over 40 years, took Xarelto and later died of a hemorrhagic stroke (bleeding in the brain). ![]()
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