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Boehringer Ingelheim recently announced that they have developed a reversal agent for Pradaxa bleeding and are seeking approval to bring the new agent to market. If this reversal agent is approved, it could resolve the internal bleeding events attached to new-generation anticoagulants Pradaxa, Xarelto, and Eliquis.
Pradaxa has been blamed for 1,158 U.S. deaths and 12,494 serious injuries related to uncontrollable internal bleeding since it was approved by the FDA in 2010, according to the Institute for Safe Medication Practices.
The German pharmaceutical company issued a press release on March 2, 2015, stating that the company is petitioning the FDA to approve their bleeding reversal agent. This reversal agent, idarucizumab, is only set to treat Pradaxa bleeding events, but could possibly be applied to Xarelto and Eliquis as well.
The FDA granted breakthrough status to Boehringer Ingelheim in June 2014 in order to speed up the approval process for the Pradaxa bleeding antidote. Boehringer Ingelhim filed for approval of the stopping agent after receiving positive results from Phase 1 clinical trials. In the Phase 1 trials, a five-minute infusion of idarucizumab reduced the risks of bleeding in healthy and younger patients, as well as in elderly patients with kidney problems, who are believed to be at highest risk for internal bleeding.
New-Generation Anticoagulants
Boehringer Ingelheim’s Pradaxa, the first anticoagulant to be approved in the United States after the release of Warfarin, was the best-selling anticoagulant in America after it was approved in 2010. Janssen and Bayer successfully broke into the exclusive anticoagulant market with the release of Xarelto in 2011, and quickly beat out Pradaxa as the most popular anticoagulant on the market. Unfortunately, both Pradaxa and Xarelto were found to cause uncontrollable internal bleeding incidents in patients because they had no reversal agents to stop the bleeding.
With the reported development of a Pradaxa bleeding reversal agent, it seems that Boehringer Ingelheim has got the jump once again in the anticoagulant market. Understandably, Boehringer Ingelheim is excited for the possible release, with representatives emphasizing the benefits it would bring to the medical community as well as the patient community.
If idarucizumab is approved, Pradaxa will be the first of the new-generation anticoagulants to get a reversal agent for internal bleeding. However, the successful progress from Boehringer has sparked some competition.
Pfizer and Bristol-Myers are developing a reversal agent for their new-generation anticoagulent, Eliquis, and the pharmaceutical company Portolo Pharmaceuticals is developing the antidote Andexanet alfa in collaboration with Janssen Pharmaceuticals, Bayer Pharmaceuticals, Bristol-Myers, and Pfizer. The companies reported positive test results in clinical trials, indicating that Andexanet alfa could be an effective reversal agent.
Overview of Anticoagulant Bleeding Complications
Concern over anticoagulant bleeding incidents began with Warfarin’s approval in 1954. However, Warfarin included several safety precautions including periodic dose adjustments and a reversal agent.
In the event of a Warfarin bleeding incident, patients would apply vitamin K to slow down the flow of blood. Additionally, the frequent doctor visits and dose adjustments allowed physicians to closely monitor patients, and most likely prevented many avoidable bleeding incidents.
The newer anticoagulants have no such check-up requirements, no dose adjustments, and, to date, no reversal agent.
Even with the progress of anticoagulant bleeding reversal agents being developed, it has come too late for many patients who suffered internal bleeding events. Boehringer Ingelheim has faced over 4,000 product liability lawsuits claiming that the drug company failed to provide adequate safety warnings on Pradaxa’s warning label.
Boehringer Ingelheim eventually settled these Pradaxa lawsuits for $650 million. Xarelto is now facing the same litigation backlash, with former patients alleging similar injuries.
In general, Pradaxa lawsuits are filed individually by each plaintiff and are not class actions.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The Pradaxa attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or Pradaxa class action lawsuit is best for you. Hurry — statutes of limitations may apply.
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