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FDA Approval of Pradaxa Reversal Agent is Too Late for Many Internal Bleeding Victims

In October 2015, after 5 years on the market, Federal drug regulators approved a reversal agent for the blood thinner Pradaxa, but the antidote comes too late for many former Pradaxa users who suffered severe bleeding complications while taking the controversial anticoagulant medication, which has been linked to thousands of reports of uncontrollable bleeding and other serious adverse events.

If you believe you have been harmed by uncontrollable bleeding side effects of Pradaxa or other devastating injuries, consult an experienced Xarelto/Pradaxa internal bleeding attorney today for legal help. You may be entitled to financial compensation for your bleeding injuries, hospital bills, lost wages, pain and suffering and other damages, which you can pursue by filing a Xarelto or Pradaxa bleeding lawsuit today.

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Pradaxa and Xarelto Blood Thinners Used by Millions

When Pradaxa (dabigatran) first came to market in October 2010, it was aggressively marketed by its manufacturer, Boehringer Ingelheim, as a superior alternative to warfarin, which has been the go-to anticoagulant in the United States for decades. According to Boehringer, Pradaxa requires less patient monitoring during treatment and reduces the risk of strokes and other side effects, and many patients were switched to the new-generation blood thinner as a result of these claims. In 2011 alone, Boehringer Ingelheim spent $464 million to promote Pradaxa, and by August 2012, more than 3.7 million patients in the United States had filled prescriptions for the blood thinner.

Lawsuits Alleging Bleeding Injuries from Pradaxa and Xarelto

Perceived by many as a safe and effective anticoagulant drug, Pradaxa actually carries a serious risk of side effects, including hemorrhaging and uncontrollable internal bleeding, and just two years after its arrival on the market, the blood thinner was blamed for more than 500 patient deaths. It was stated that in 2011 alone, the FDA received 817 reports of adverse events involving Pradaxa, but a QuarterWatch report released that same year identified 3,781 serious adverse events from Pradaxa in 2011, 542 of which were fatal.

Thousands of victims of Pradaxa bleeding complications have taken legal action against Boehringer Ingelheim, filing product liability lawsuits alleging that the drug maker failed to adequately warn consumers and the medical community about the potential for Pradaxa to cause severe and potentially life-threatening bleeding problems. In May 2014, Boehringer settled more than 4,000 of these claims, agreeing to pay $650 million to resolve all of the Pradaxa multidistrict litigations (MDLs) that had been created.

FDA Approves Pradaxa Reversal Agent

It wasn’t until October 2015, that the U.S. Food and Drug Administration (FDA) finally approved a reversal agent called Praxbind (idarucizumab) as the first antidote for this new class of blood thinners, indicating that the drug can be used to safely reverse the blood-thinning effects of Pradaxa in the event of a bleeding complication. It is hoped that, as Praxbind becomes more widely available, the number of potentially life-threatening bleeding injuries from Pradaxa can be significantly reduced. According to one study published in the New England Journal of Medicine in June 2015, Praxbind may be able to stop Pradaxa’s blood-thinning effects within minutes, allowing doctors to treat bleeding side effects that occur among users. To this day, Xarelto still does not have an approved reversal agent, yet continues to be prescribed.

An Experienced Pradaxa Attorney Can Help

In the meantime, Boehringer Ingelheim has faced significant criticism and a number of lawsuits claiming that the drug manufacturing company never should have been allowed to sell Pradaxa without a reversal agent in the first place, and victims of Pradaxa bleeding complications may be entitled to financial compensation from Boehringer for their injuries and medical expenses. If you or a loved one took the anticoagulant Pradaxa in the past, and you have since suffered an uncontrollable bleeding side effect, contact the knowledgeable Pradaxa/Xarelto attorneys at the Monroe Law Group today at 866-308-1092, at intake@monroelawgroup.com, or by completing the form on this page to discuss your legal options. With a reputable product liability lawyer on your side, you can protect your legal rights and seek fair and timely reimbursement for your medical bills, losses, and/or pain and suffering.

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