Pradaxa, one of the newer anticoagulant medications available in the U.S., was promoted and marketed as an improvement over warfarin, a blood-thinning drug that has been in use for decades.

The risk of bleeding with Pradaxa, however, soon overshadowed some of the benefits its manufacturers proclaimed, such as not needing to monitor blood or make dietary changes. The blood-monitoring and dietary changes were an unfortunate inconvenience associated with warfarin.

The U.S. Food and Drug Administration approved Pradaxa, also known generically as dabigatran, for the domestic market on Oct. 19, 2010. Like warfarin, Pradaxa is a blood-thinner used to treat atrial fibrillation, deep vein thrombosis, and pulmonary embolism.

These three conditions involve blood clots that can travel from the deep veins of the legs to the heart and lungs and cause heart attack and respiratory arrest. With the ineffective heart-pumping of atrial fibrillation, blood clots can form as well and travel to the brain causing stroke.

Deep vein thrombosis and pulmonary embolism can be common after having a total knee or hip replacement. Pradaxa or warfarin is often used for several weeks after joint arthroscopy to reduce this risk.

Risk of Bleeding with Pradaxa

The risk of bleeding with Pradaxa quickly became apparent after its approval and release in the U.S. market. After just two years of availability, around 500 deaths had been linked to Pradaxa.

Numerous cases of hemorrhaging underscored the risk of bleeding with Pradaxa. There were surviving patients and families that reported uncontrolled situations of bleeding with no known remedy available.

When it first hit the market, Pradaxa set itself apart from warfarin in one very critical way: it did not possess an antidote for its blood-thinning action. Doctors and other critical care medical professionals have known for years that a rapid infusion of vitamin K can and usually will reverse the effects of warfarin. No such antidote was available for Pradaxa patients.

Patients faced this heightened risk of bleeding with Pradaxa until October 2015, five years after the initial approval of the anticoagulant medication. It was then that the FDA fast-tracked the antidote Praxbind, also known generically as idarucizumab, through the approval process.

As a result of the lag between approval of Pradaxa and approval of its antidote, many people were exposed to the risk of bleeding with Pradaxa and either were severely injured or died.

Many patients and their families filed product liability lawsuits against Boehringer Ingelheim, the drug’s manufacturer, for failing to warn consumers about these risks.

In May 2014, the pharmaceutical giant settled several thousand lawsuits of this nature with a $650 million settlement payment. An investigation is still underway seeking other individuals that may have suffered as a result of Boehringer Ingelheim’s negligence during this five-year period.

If you or a loved one has been injured after ingesting this anticoagulant medication, a Pradaxa lawyer can answer your questions and can discuss your case to see if legal recourse is right for you.