For patients taking Pradaxa, traumatic injuries, gastrointestinal bleeding, and Pradaxa hemorrhage may be much more dangerous than for other patients taking other blood thinners.

Pradaxa, also known by its generic name dabigatran, is an anticoagulant drug. It’s now approved by the FDA as a way to prevent stroke in patients with non-valvular atrial fibrillation. It can also be used to prevent other blood clot-related conditions like pulmonary embolism and deep vein thrombosis.

Before Pradaxa came along, the market for anticoagulants was dominated by one drug: warfarin, also sold under the brand name Coumadin.

Warfarin treatment comes with certain disadvantages. It requires the patient to undergo regular blood testing and dosage adjustment. Patients must also live with dietary restrictions, avoiding foods that contain higher levels of vitamin K.

Pradaxa was developed as an alternative to warfarin that would not have the same drawbacks. Pradaxa patients don’t have to submit to blood testing or dietary restrictions.

But Pradaxa can’t avoid creating an elevated risk of excessive bleeding, a drawback inherent in all anticoagulant drugs. By their nature, these drugs impair the body’s natural ability to slow and stop bleeding.

Reports of adverse events associated with Pradaxa reflect this elevated risk of bleeding. Within two years after Pradaxa entered the market, it had been implicated in more than 500 reports of patient deaths.

The lack of a Pradaxa antidote only raised the stakes for these patients. For the first few years that Pradaxa was on the market, there was no antidote available that could reverse its anticoagulant effect. Therefore, patients who suffered a Pradaxa hemorrhage or who suddenly needed emergency surgery weren’t able to reverse Pradaxa’s anticoagulant effect using medication.

In October 2015, the FDA finally approved a Pradaxa antidote. By that time, however, Pradaxa patients had spent five years living with the risk of uncontrollable Pradaxa bleeding.

Litigation Over Pradaxa Hemorrhage, Gastrointestinal Bleeds

Thousands of patients who suffered bleeding injuries, including Pradaxa hemorrhage, after taking Pradaxa joined in a federal mass litigation set up in an Illinois federal court.

Typical of these plaintiffs’ claims was that the drug’s manufacturer, Boehringer Ingelheim, failed to provide an adequate warning about the bleeding injuries that can result from using Pradaxa.

Many claimed they had not been informed of the real risks before they chose to take Pradaxa, or that the drug had no available antidote. They allege that if they had been fully aware of factors like these, they never would have taken Pradaxa.

Boehringer Ingelheim was fully aware of these risks, the plaintiffs claim. Yet the company allegedly failed to pass on the vital safety information it had in its possession. Plaintiffs accuse Boehringer Ingelheim of actively concealing this information to avoid decreasing Pradaxa sales.

The first wave of this litigation came to a head in May 2014. Boehringer Ingelheim struck a settlement deal with around 4,000 existing claimants, promising settlement payouts of $650 million.

But Pradaxa is still on the market, and Pradaxa hemorrhage is still a risk patients face. Now that the federal litigation has been wrapped up, consumer advocates expect a second round of Pradaxa litigation will take hold in state courts throughout the country.