When manufacturer Boehringer Ingelheim Pharmaceuticals approved Pradaxa on Oct. 19, 2010, the drug quickly gained popularity for its convenient dose schedule.

It was advertised as superior to Warfarin, but not long after its release patients started reporting incidents of uncontrollable internal bleeding.

Within two years of its release, the drug, approved to prevent blood clots and stroke in high risk patients with atrial fibrillation, was linked to over 500 deaths and exposed Boehringer Ingelheim to serious legal trouble.

In May 2014 the German pharmaceutical giant settled over 4,000 Pradaxa bleeding lawsuits that alleged serious injuries or deaths related to the medication, agreeing to pay over $650 million in the settlement.

According to the allegations made in the lawsuits, the bleeding injuries and deaths occurred because there was no Pradaxa antidote to reverse bleeding problems. That may soon change, as a Pradaxa reversal agent will reportedly soon be widely available.

Overview of Pradaxa Antidote Approval

The FDA approved Boehringer’s Pradaxa antidote on Oct. 16, 2015. The antidote, Praxbind (idarucizumab), was approved under an accelerated FDA approval process for unaddressed medical needs that will bring benefits to the patient population.

Before its approval, the Pradaxa reversal agent was studied in three trials that included a total of 283 healthy Pradaxa patients who volunteered to participate in the studies. The healthy patients who were given Praxbind showed an immediate reduction in the amount of Pradaxa in their bloodstream. The effect lasted for at least 24 hours.

A separate trial involved 123 Pradaxa patients who received the Pradaxa antidote to treat uncontrolled bleeding or because they needed emergency surgery. The results showed that Praxbind fully reversed the blood thinning and anti-clotting effects of Pradaxa in 89 percent of patients within four hours of receiving the Pradaxa reversal agent.

Although the Pradaxa antidote is welcome news for future Pradaxa users, the solution comes too late for patients and families who have already been injured or lost a loved one from uncontrollable bleeding side effects.

For those patients and their families who have already suffered from Pradaxa bleeding or who are wondering whether their risks can be reversed or cured, talking with an attorney may be a prudent first step. Experienced attorneys are available to discuss whether a Pradaxa lawsuit against Boehringer Ingelheim is right for you.