Pradaxa is a blood thinner used for stroke prevention. Designed to require less maintenance and create fewer side effects than its predecessor, warfarin, Pradaxa received U.S. Food and Drug Administration (FDA) approval in October 2010.

By 2012, there were more than 3.7 million Pradaxa prescriptions in the United States. The German manufacturer, Boehringer Ingelheim, reached the $1 billion mark in total sales in the same year.

Along with these immense sales came claims that the anticoagulant caused 542 deaths due to uncontrollable Pradaxa side effects, including internal bleeding and hemorrhaging.

What Is Pradaxa?

Pradaxa (dabigatran) is an anticoagulant. It, along with warfarin, is used to treat those who suffer atrial fibrillation (AF) and face risk of blood clots and stroke. However, while warfarin and Pradaxa treat the same condition, they function very differently. Most notably, frequent blood tests and dosage adjustments are not required for Pradaxa users as is the case with warfarin.

Pradaxa is part of the drug class labeled thrombin inhibitors. Thrombin is a clotting protein in the body. Pradaxa works to inhibit thrombin so that the patient’s blood is thinned and less likely to clot, which often leads to stroke. It is advised that those with kidney problems should take lower doses and be more carefully monitored.

Common Pradaxa Side Effects

As with other anticoagulants, it is not uncommon for Pradaxa patients to experience bruising or bleeding due to minor cuts. If not treated carefully, bleeding complications can occur.

Excessive bleeding is most common in Pradaxa patients who are over the age of 75, have kidney problems, or suffer a stomach ulcer that has caused internal bleeding in the intestines or stomach. Other than these standard risks, Pradaxa has minimal side effects. However, patients should not confuse fewer side effects with increased safety.

Common Pradaxa side effects may include nausea, indigestion, heartburn and stomach pain; there stands, however, the risk of more serious complications.

Severe Pradaxa Side Effects

Severe Pradaxa side effects may include heart attack, liver failure, uncontrolled internal bleeding or hemorrhaging, and death in some cases. While bleeding can be a common side effect, serious cases can result in brain and central nervous system hemorrhaging. These conditions can be equally as harmful as a stroke if they become out-of-hand.

In 2010, just six months after it was approved by the FDA, the agency received over 4,000 reports of adverse events relating to Pradaxa. Of these, 542 resulted in death of the patient.

It is recommended that patients taking Pradaxa seek immediate medical attention if they experience symptoms such as unusual bruising, pink or brown urine, or coughing up blood.

Pradaxa Lawsuits

In May 2014, Boehringer Ingelheim Pharmaceuticals agreed to settle around 4,000 claims regarding Pradaxa for a total of approximately $650 million. The settlement covers claims in both state and federal courts and Boehringer Ingelheim did not admit to any liability.

Although Boehringer agreed to settle thousands of Pradaxa lawsuits, the drug maker is still facing thousands more claims in federal court, alleging that users suffered severe and often fatal bleeding problems after using the controversial anticoagulant.

Over 2,600 Pradaxa Lawsuits are currently consolidated in a multidistrict litigation, In re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation, MDL 2385, in the U.S. District Court for the Southern District of Illinois.