In the past five years, Pradaxa bleeding litigation has spawned hundreds of product liability lawsuits and record-breaking settlements.

Now, the manufacturer of the new generation blood thinner, Boehringer Ingelheim Pharmaceuticals, may soon find redemption in the public’s eye, as its bleeding antidote may be approved by the end of this year.

Pradaxa Antidote Set For FDA Review

Early results from a new study indicates that an experimental drug may be able to reverse the Pradaxa bleeding effects, which may be released by the end of 2015.

In April 2015, the FDA stated that it would conduct a priority review of the application, in order to speed along the approval process for the potential Pradaxa bleeding antidote, Idarucizumab, once the current study is complete.

The ongoing study was recently published in the New England Journal of Medicine and is being conducted to determine whether or not Idarucizumab would be an effective reversal agent for Pradaxa bleeding injuries.

According to the Pradaxa antidote study, the mechanism behind Idarucizumab is the binding process that streamlines the drug’s blood-thinning abilities.

While the reversal effects of this potential Pradaxa antidote was not immediately active, normal blood clotting ability was restored in minutes while not promoting adverse blood-clotting formations.

Essentially, experts are excited for Idarucizumab because it could be a safe method of stopping internal bleeding for Pradaxa patients, as vitamin K does for Warfarin patients.

Overview of Pradaxa Bleeding Complications

When Pradaxa was approved in 2010, it was the first anticoagulant to breach the market since the release of Warfarin in 1936. Boehringer Ingelheim Pharmaceuticals reportedly spent over $400 million to promote the drug and was met with very profitable rewards. By August 2012, more than 3.7 million patients had been prescribed Pradaxa, successfully outpacing Warfarin in popularity.

Pradaxa’s success inspired American pharmaceutical companies to try their luck in the lucrative anticoagulant market, resulting in the release of Xarelto and Eliquis; these three drugs together have since been categorized as new generation blood thinners.

However in those two years of its arrival, Pradaxa has been blamed for nearly 600 deaths due to sudden uncontrollable internal bleeding events.

Each of these new anticoagulant drugs were advertised to be faster-acting and more efficient than Warfarin, along with being prescribed in a single dose. In contrast, Warfarin patients are required to frequently see their physicians for dose adjustments and are under constant blood monitoring.

However, medical experts believe that if these requirements were conveyed to Pradaxa and the other new generation anticoagulants users, then numerous bleeding events could have been prevented.

Pradaxa Lawsuits

If patients using Pradaxa experience an internal bleeding event and are not hospitalized in time, the bleeding injuries could become fatal.

This Pradaxa side effect has spurred thousands of patients, who were prescribed the anticoagulant to prevent stroke, to file Pradaxa bleeding lawsuits against Boehringer Ingelheim Pharmaceuticals.

The litigation movement came to a head in May 2014, when the drug maker settled more than 4,000 Pradaxa bleeding lawsuits for $650 million.

While Boehringer Ingelheim has made great strides in a potential antidote, for many patients who experienced a dangerous internal bleeding event, the Pradaxa antidote is too late.