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New research indicates that Praxbind appears to be an effective reversal agent to counter the bleeding side effects of Pradaxa, with results showing that it is working as it should to quickly stop bleeding events that may occur among individuals using the controversial new-generation anticoagulant.
In a study published last week in the New England Journal of Medicine, researchers supported by Boehringer Ingelheim, the manufacturer of Pradaxa, indicate that Praxbind (idarucizumab) rapidly reversed the blood thinning effects of their popular drug in virtually all patients. The widespread availability of the Pradaxa reversal agent may greatly increase the safety of the drug, and provide Boehringer Ingelheim a dramatic boost in sales for their beleaguered drug.
The study comes amid continuing concerns about the bleeding risk of Pradaxa and other members of the same new-generation of oral anticoagulants. According to a recent analysis of adverse event reports received by the FDA last year, bleeding problems with Pradaxa and similar anticoagulants were linked to more than 3,000 deaths last year. Most of those deaths were associated with Xarleto and Eliquis, which are the two most widely used novel oral anticoagulants, and do not have approved reversal agents.
Pradaxa, Xarelto, Eliquis and other new-generation anticoagulants were released in recent years without a safe and effective reversal agent, leaving many doctors helpless to control or stop bleeding problems that develop among users. The drug makers have promoted the novel oral anticoagulants as superior alternatives to warfarin, which has been the go-to treatment for blood clots for decades among individuals with atrial fibrillation. However, the blood thinning effects of warfarin can be quickly reversed with a dose of vitamin K and fresh frozen plasma.
In this latest study, researchers conducted a multicenter, open-label study involving 503 Pradaxa patients to determine the effectiveness of 5g intravenous Praxbind. The participants were divided into two groups; 301 of whom were given Praxbind due to uncontrolled bleeding events, and 202 who were given the drug in preparation for surgery, to prevent bleeding problems during the procedure.
Praxbind was approved by the FDA in 2015, with the hopes of making the drug substantially safer. According to these new findings, a single 5g dose was effective in 98% of patients, with a median cessation time of 2.5 hours for bleeding to stop.
At one time, Boehringer Ingelheim faced more than 4,000 Pradaxa lawsuits brought on behalf of individuals nationwide who suffered severe and sometimes fatal bleeding problems, alleging that the drug maker failed to adequately warn consumers or the medical community about the serious bleeding risk or lack of a reversal agent. Following several years of litigation, the drug maker reached Pradaxa settlements in 2014, agreeing to pay $650 million to resolve cases, with an average payment of about $150,000 per claim.
In recent years, as lawsuits over Pradaxa mounted, the competing new-generation drugs Xarelto and Eliquis have seen their sales increase. However, neither has an FDA approved reversal agent. More than 18,000 Xarelto lawsuits are currently pending against the makers of that drug, and a growing number of Eliquis lawsuits started to be filed over the past year.
Portolo Pharmaceuticals proposed a reversal agent for Xarelto and Eliquis in September 2016, but the FDA rejected it, calling for additional information on the manufacturing process, and data on whether it can be used with other Factor Xa inhibitors, like Savaysa. Portolo has indicated it intends to resubmit the application for approval later this month.