The popular and oft-prescribed blood thinner Pradaxa (dabigatran) is a blockbuster medication, earning manufacturer Boehringer Ingelheim Pharmaceuticals more than $1 billion in sales revenue. The first of a new category of anticoagulants, Pradaxa hit the market as an alternative to a blood thinner called Coumadin (warfarin), which was used for nearly 60 years.

According to the U.S. Food and Drug Administration (FDA), hundreds of thousands of U.S. patients have used the new generation blood thinner. Thousands of these patients have experienced serious Pradaxa adverse effects, including uncontrollable internal bleeding.

About Pradaxa

Approved for use in October 2010, Pradaxa is known as a direct thrombin inhibitor. It is available in 75 mg and 150 mg capsules. The new-generation anticoagulant is used to prevent strokes in patients who suffer from atrial fibrillation. Patients with atrial fibrillation may be at a higher risk of blood clots, which can cause a stroke if they travel to the brain.

In some countries, Pradaxa is approved to prevent venous thromboembolism, although it is not approved in the U.S. for this use.

Pradaxa Bleeding Problems

Pradaxa has become associated with serious bleeding-related injuries. Many patients have reported experiencing gastrointestinal bleeding, severe hemorrhaging, strokes, heart attacks, and other serious Pradaxa complications and injuries. These reports have prompted multiple government reviews, numerous medical studies evaluating the drug’s safety and effectiveness, and thousands of Pradaxa lawsuits.

The Food and Drug Administration (FDA), the federal agency responsible for regulating pharmaceutical drugs, has annually received over 3,000 adverse event reports concerning Pradaxa since 2010. The most commonly reported problems are bleeding complications such as severe hemorrhaging and gastrointestinal bleeding. Other patients have reported suffering strokes and heart attacks.

According to the Institute of Safe Medication Practices (ISMP), Pradaxa was tied to more bleeding events and deaths in 2011 than any of the 800 other medications reviewed by the FDA. In a drug safety communication posted May 2014, the agency reviewed a recent Medicare study that compared warfarin and Pradaxa in GI bleeding events. Health regulators concluded that “the study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin.”

Pradaxa Lawsuits

Patients who suffer injuries after taking Pradaxa have legal options. When a pharmaceutical drug like Pradaxa is responsible for patient injuries, patients can sue the drug manufacturer. These product liability lawsuits seek to hold manufacturers accountable for their dangerous and defective products.

Patients who successfully sue can recover compensation from the manufacturer. This can cover the cost of medical bills, lost wages from time off work, and the pain and suffering experienced by patients with serious medical issues.

Thousands of patients have already filed Pradaxa lawsuits. These lawsuits contend that Boehringer Ingelheim failed to warn doctors and patients about the increased risk of bleeding related injuries associated with the anticoagulant. They also contend that the company defectively designed Pradaxa in a manner that made the drug unsafe for patients.

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

Although Boehringer Ingelheim Pharmaceuticals 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.

2,612 Pradaxa lawsuits are currently consolidated in a multidistrict litigation known as In re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation, MDL 2385, in the U.S. District Court for the Southern District of Illinois.