The prescription drug Pradaxa (dabigatran) has been prescribed to more than a million patients since the Food and Drug Administration (FDA) approved its entry into the market in 2010. It is a blood thinner designed to treat patients who suffer from a condition called atrial fibrillation, and it’s meant to prevent stroke by thinning the blood.

The drug was the first of a group of new generation anticoagulants, or blood thinners, and it was marketed as a safer alternative to the traditional warfarin, a drug that had been around for more than 55 years at the time.

Within its first two years on the market, the manufacturer of Pradaxa, Boehringer Ingelheim Pharmaceuticals, generated more than $1 billion in revenue from Pradaxa sales, and more than 725,000 patients in the U.S. were prescribed the drug. Unfortunately, thousands of these patients have experienced excessive and uncontrollable Pradaxa internal bleeding, including fatal incidents of brain and gastrointestinal bleeding.

As early as 2011, the FDA received over 3,800 adverse events reports from Pradaxa users and subsequently issued a safety warning. At the time, the agency noted that Pradaxa use had resulted in the highest number of both adverse events and deaths of the nearly 800 drugs the agency monitors regularly, with Pradaxa associated with more than 500 fatalities.

Pradaxa Bleeding Complications

Manufactured by Boehringer Ingelheim, Pradaxa is manufactured and promoted to act as an oral anticoagulant, or blood thinner. While on Pradaxa, however, the patient has no convenient way of monitoring their blood as patients on warfarin do.

All blood thinners pose a risk for dangerous internal bleeding, but should a Pradaxa bleeding event occur, there is no way to easily reverse the effect other than emergency dialysis, which is unsafe for those in an unstable condition because it can cause large intracranial hemorrhage.

These complications were worsened by the fact that there is no way to reverse the effects of Pradaxa bleeding in the case of an emergency, rendering doctors unable to stop excessive bleeding to save the patient’s life.

Within a few short months on the market, Pradaxa was already linked to more than 300 complications; reports included thousands of cases of hemorrhage, kidney failure and stroke. These Pradaxa bleeding complications are grave and can be fatal. Of the over 3,800 cases reported since its release, the drug was claimed responsible for 542 Pradaxa bleeding deaths.

Pradaxa Bleeding Lawsuits

Boehringer Ingelheim Pharmaceuticals failed to warn the medical community and consumers of the severe Pradaxa risks associated with their blood thinner, including uncontrollable bleeding. They also failed to provide a Pradaxa antidote to reverse the effects of the drug in case of emergency, which has cost hundreds of patients their lives.

If you or a loved one has experienced complications or death as a result of Pradaxa, you may be eligible to file a Pradaxa bleeding lawsuit against Boehringer Ingelheim Pharmaceuticals for the pain and loss Pradaxa use has caused.