Patients taking blood thinners might not realize they could suffer from Pradaxa bleeding complications.

Pradaxa, generically known as dabigatran, was FDA-approved in 2010 as one of the new oral anticoagulants (NOACs). The drug belongs to a drug class called direct thrombin inhibitors, commonly called blood thinners.

Patients suffering from atrial fibrillation, a type of irregular heartbeat, are at an increased risk of stroke because the blood pools for a longer period of time. Blood thinners often are prescribed to reduce the risk of blood clots.

Blood thinners also are prescribed for patients who are at risk of blood clots forming in the veins of the legs (deep vein thrombosis) or lungs (pulmonary embolism).

For nearly 50 years, Coumadin (warfarin) was the only blood thinner on the market. Patients on Coumadin must undergo periodic blood tests to ensure that a maintenance level of the medication is maintained. Dietary restrictions also apply. In the event of an unexpected surgery or accident, the patient can undergo an IV dose of vitamin K to stem the anticoagulating effects of Coumadin.

Pradaxa was introduced to the market with great fanfare by drug manufacturer Boehringer Ingelheim Pharmaceuticals, which attempted to convince the medical community and the public that Pradaxa was superior to Coumadin.

Pradaxa marketing focused on the fact that with its new blood thinner, there was no need for a regular blood test to see if the blood-thinning level was within the correct range. Pradaxa users also were told they had no dietary restrictions.

Within a month of the drug’s 2010 release, Pradaxa bleeding complications became known. A reported 260 patients bled to death after taking Pradaxa in the first month. In 2011, an additional 540 patients fatally bled out after taking Pradaxa.

Pradaxa Bleeding Complications

Pradaxa blocks thrombin, which is a clotting protein in the blood. Mild side effects can include bruising, minor bleeding, indigestion and heartburn. Pradaxa bleeding complications can include uncontrollable brain bleeding and gastrointestinal bleeding, both of which can prove fatal.

For the first several years that Pradaxa was on the market, there was no known antidote available for the anticoagulating properties of Pradaxa. Once a patient began experiencing a hemorrhage, there was no other medication that could reduce the bleeding.

Boehringer Ingelheim allegedly held an antidote known as Praxbind even before Pradaxa was sold in the U.S. Boehringer Ingelheim waited until February 2015 to seek FDA approval of their antidote, which finally became available in autumn of 2015. By that time, the company was facing thousands of lawsuits.

In May 2014, Boehringer Ingelheim agreed to pay $650 million to settle 4,000 Pradaxa lawsuits filed over Pradaxa bleeding complications. The pharmaceutical company did not admit any wrongdoing upon agreeing to the settlement.

If you or someone you love has suffered from Pradaxa bleeding complications, you could benefit from speaking with a lawyer regarding your legal options.