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More than five years after the introduction of the controversial anticoagulant Pradaxa, and following thousands of reports involving uncontrollable bleeding suffered by users, the recently approved reversal agent Praxbind is now available in many hospitals nationwide.
In a press release issued March 8, Boehringer Ingelheim announced that Praxbind, a specific reversal agent for Pradaxa, is stocked in more than 2,200 hospitals throughout the United States. In addition, the drug maker has published a Praxbind locator tool on it’s website, which helps identify facilities that have the drug in stock near health care providers and patients.
Pradaxa (dabigatran) first hit the market in October 2010, as the first member of a new generation of anticoagulants that have been aggressively marketed as a superior replacement for warfarin, which has been the go-to treatment for prevention of blood clots for decades. However, as more patients were switched to this new drug, a surprising number of serious and often fatal injuries were linked to Pradaxa bleeding problems, where doctors were unable to stop or reverse hemorrhaging or major bleeds.
Similar problems with uncontrollable bleeding have plagued other members of this new generation of drugs, known as novel oral anticoagulants, which also include the blockbuster medications Xarelto (rivaroxaban) and Eliquis (apixaban).
Unlike warfarin, which has a known and effective antidote to reverse the blood thinning effects of the drug in the case of an emergency, Pradaxa and other members of this new class were introduced without a reversal agent. As a result, doctors have often been left helpless in stopping bleeds on Pradaxa, Xarelto and Eliquis, increasing the risk of severe injury or death.
In October 2015, the FDA approved Praxbind (idarucizumab) as the first antidote for this new class of novel oral anticoagulants, indicating that it is safe and effective as a reversal agent for Pradaxa.
As the antidote becomes more widely available, it is hoped that the number of severe and catastrophic bleeding injuries on Pradaxa will be significantly reduced.
Pradaxa Uncontrollable Bleeds
Boehringer Ingelheim has faced sharp criticism and a number of product liability lawsuits alleging that they never should have sold Pradaxa without an available reversal agent. Similar Xarelto lawsuits and Eliquis lawsuits have also been filed against the makers of those competing medications, which still do not have antidotes approved by the FDA.
In 2014, Boehringer Ingelheim agreed to pay more than $650 million in Pradaxa settlements to resolve thousands of claims brought by individuals throughout the U.S. However, the drug maker has continued to face new Pradaxa lawsuits as injuries and wrongful deaths have continued to occur as a result of uncontrollable bleeding.
The widespread availability of Praxbind is expected to stem the number of bleeding injuries and new lawsuits substantially.
“Boehringer Ingelheim is proud to have been able to make PRAXBIND, the first specific reversal agent for a NOAC, available, and that we have been able to distribute it broadly nationwide,” Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc, said in the press release issued this week by the drug maker. “In the rare event that a patient may need PRAXBIND, it is critical that it is readily available.”
Xarelto, Eliquis Reversal Agent Under Consideration
In December, Portola Pharmaceuticals submitted a drug approval application to the FDA for a reversal agent that the company says will work on Xarelto and Eliquis bleeding problems as well.
Known as Annexa (andexanet alfa), that drug was submitted after phase III clinical trials indicated it could stop most cases of Xarelto and Eliquis bleeding in minutes.
There are currently more than 4,000 lawsuits pending over Xarelto bleeding problems and that number is expected to continue to grow rapidly, as the medication has become the most widely used novel oral anticoagulant in the class.
In the federal court system, the cases are centralized in the Eastern District of Louisiana as part of an MDL, or multidistrict litigation, where a small group of bellwether trials are expected to begin later this year if Xarelto settlements are not reached to resolve the claims.