Pradaxa, also known as dabigatran, did not have an antidote for its adverse internal bleeding complications until 2015.

It was in 2010 that the U.S. Food and Drug Administration approved Pradaxa for treatment of people with atrial fibrillation. In April 2014, the FDA approved Pradaxa treatment for people with deep vein thrombosis (DVT) and pulmonary emboloism (PE).

The late development and approval for the antidote allegedly led to hundreds of casualties, alongside thousands of lawsuits against Pradaxa’s manufacturer Boehringer Ingelheim.

Since the approval in 2010, moreover, Pradaxa bleeding side effects have been linked to over 1,000 fatalities in patients who took this drug.

Pradaxa is an anticoagulant medication that unlike warfarin does not have to be monitored by blood tests. It is a direct thrombin inhibitor, meaning that it inhibits both free and fibrin-bound fibrin.

In October 2015, the FDA later approved Pradaxa’s antidote for the reversal of Pradaxa’s anticoagulant effects, called Praxbind. Praxbind also known as idarucizumab, reverses the effects of dabigatran.

As an anticoagulant, Pradaxa is used to prevent strokes in patients with an atrial fibrillation, also known as an abnormal heart rhythm. It also treats patients with deep venous thrombosis, the formation of a blood clot in the body’s lower extremity, and pulmonary embolism, the condition in which one or more blood vessels in the lungs becomes blocked by a blood clot.

Many Pradaxa bleeding side effects have been reported in connection with this medication. By 2014, Pradaxa had been linked to more than 1,000 deaths. Moreover, in studies that compared Pradaxa with warfarin, researchers reported that patients taking Pradaxa showed a significantly higher frequency of gastrointestinal bleeding.

The hypothesis behind the risk of gastrointestinal bleeding with Pradaxa is that dabigatran capsules contain tartaric acid, which lowers the pH level of the gastric environment. Reports emphasize that a decrease in pH plays a role in the increased risk of Pradaxa bleeding side effects. The lower pH has also been linked to dyspepsia, the pain or discomfort in the upper middle part of the stomach.

Pradaxa Litigation

Due to Pradaxa bleeding side effects, thousands of claims were filed by patients taking Pradaxa and they were consolidated into a multidistrict litigation (MDL) in August 2012. Defendant Boehringer Ingelheim, the manufacturer of Pradaxa, agreed in May 2014 to settle around 4,000 lawsuits for payments totaling $650 million.