Over the past several years, numerous patients across the United States have filed blood thinner lawsuits against Pradaxa manufacturer Boehringer Ingelheim. After facing countless accusations of negligence from the claimants and eventually came to a settlement, the pharmaceutical company has developed a Pradaxa antidote.

Pradaxa is a new generation blood thinner, which was approved by the FDA in 2010. It was the first drug to be approved for anticoagulant purposes since Warfarin, and quickly overtook its predecessor in popularity. However, until recently, no Pradaxa reversal agent had existed for patients who suffered uncontrollable internal bleeding.

This led to patients filing blood thinner lawsuits against Boehringer Ingelheim, for concealing vital safety information and other negligence charges. Each of the blood thinner lawsuits alleged that the German pharmaceutical company had failed to warn them against uncontrollable internal bleeding injuries, while no Pradaxa reversal agent was available.

Overview of Praxbind Approval

On Oct. 16, 2015, the FDA had approved Praxbind (Idarucizumab) to reverse the internal bleeding effects of the drug. Patients who take Pradaxa and need emergency treatment, may be approved to receive the Pradaxa antidote. The FDA approved Praxbind after consistent positive results came from pharmacokinetic and pharmacodynamic studies.

In one study, 224 health Pradaxa patients who were given Praxbind after experiencing bleeding injuries had observed the effects in a 24 hour period. The findings showed that the Pradaxa reversal agent was effective in reversing the blood thinner effects.

In another trial, 123 Pradaxa patients had represented the data in a case series of patients requiring emergency intervention after experiencing internal bleeding injuries. According to the results of this case series, 89 percent of the patients had their injuries completely reversed by the Pradaxa antidote within four hours of implementation.

While the researchers did observe minor side effects from Praxbind, with five percent of the patients experiencing headaches, hypokalemia, delirium, constipation, pyrexia, and pneumonia. In addition, 26 out of 123 patients in one trial died due related complications with the Pradaxa reversal agent.

Boehringer explained that the complications, were due to the increase risk of thrombosis patients experience after receiving the Pradaxa reversal agent. With consistent positive results, the FDA not only approved Praxbind but also gave it accelerated approval.

Even though there is now an approved Pradaxa reversal agent, it has come nearly five years after the drug’s release onto the market. This means that for numerous patients, the Pradaxa antidote came too late after already suffering or dying from internal bleeding injuries.

Many alleged that Pradaxa lacked sufficient indications on the product’s warning label, which left numerous patients vulnerable to potential bleeding incidents. In May 2014, Boehringer Ingelheim had settled over 4,000 Pradaxa lawsuits for $650 million. Patients who experienced adverse bleeding effects after taking Pradaxa, may be eligible to file their own blood thinner lawsuit.