Patients who have experienced Pradaxa uncontrollable bleeding while under treatment for blood clotting and their families are filing lawsuits against German pharmaceutical company Boehringer-Ingelheim.

These plaintiffs claim the manufacturer failed to inform patients and their physicians about the risk of serious, and even fatal hemorrhaging and the lack of an antidote.

Although the FDA approved an antidote in 2015, Pradaxa has been on pharmacy shelves since 2010. Since then, thousands of patients say they face an unreasonable risk of Pradaxa uncontrollable bleeding from a product intended to save their lives.

Pradaxa – What it Is, How it Works

Pradaxa (dabigatran) was first identified in the 1980s as an effective way to suppress the production of thrombin, an enzyme that plays an important role in blood clotting. It was first approved by the European Medicines Agency in 2008; FDA approval was granted for the U.S. market two years later. It is part of a class of drugs known as Novel Oral Anti-Coagulants (NOACs), which are indicated for patients at risk for embolism (blood clotting).

NOACs such as Pradaxa have been considered an effective alternative to the old first-line treatment, warfarin. The major selling point for pharmaceutical companies has been the fact that NOACs have far fewer interactions and require far less monitoring than warfarin.

Medical Authorities Note Pradaxa Uncontrollable Bleeding

It was not long before reports of Pradaxa uncontrollable bleeding began to appear. The problem has been blamed on Pradaxa’s mechanism of action. Bleeding from warfarin could easily be stopped by giving the patient massive doses of vitamin K, which also plays a significant role in blood clotting. However, Pradaxa and other NOACs bypass vitamin K, preventing the formation of the main ingredient of blood clots (fibrin) by inhibiting the production of the key ingredient, thrombin. Therefore, vitamin K has no effect.

Until an antidote was approved in 2015, the only way to save a patient from Pradaxa uncontrollable bleeding was to administer emergency dialysis in order to get the drug out of the system quickly – an uncertain process at best.

What an FDA Study Found

In May 2014, the FDA issued a report in which Pradaxa and warfarin were compared among 134,000 patients. That study showed that Pradaxa uncontrollable bleeding of the gastrointestinal tract was more common than that caused by warfarin. Nonetheless, the authors of the study concluded that benefits outweighed the risks of Pradaxa uncontrollable bleeding.

The BMJ Investigates

In July 2014, a number of investigations were published in the British Medical Journal, accusing Boehringer-Ingelheim of concealing information that would have helped doctors to monitor their patients for Pradaxa uncontrollable bleeding. Evidence surfaced that purportedly showed the company had a financial interest in hiding the facts from health regulators since their own findings were in conflict with their claims that Pradaxa required little or no monitoring.

The Manufacturer Enters Into a Settlement

Shortly after the publication of the BMJ investigations, Boehringer-Ingelheim agreed to a $650 million settlement to victims of Pradaxa uncontrollable bleeding and their families. Nonetheless, since the drug was available for five years with no antidote, plaintiffs continue to come forward.