The release of Pradaxa (dabigatran) had inspired the release of two competitors, Xarelto and Eliquis, permanently altering the exclusive anticoagulant drug market in America.

Pradaxa was the first blood thinner to be released in the United States since Warfarin’s approval in the 1950s.

However, it was not long after its release in 2010 that patients started reporting serious reports of gastrointestinal bleeding symptoms, resulting in numerous hospitalizations and a number of deaths.

Pradaxa is typically prescribed to patients suffering from atrial fibrillation and are at a high risk for stroke, and has become a favorite amongst anticoagulant market.

This drug works by inhibiting the body’s clotting ability, which eliminates the possibility of clotting. Pradaxa is part of the drug class direct thrombin inhibitors, which shuts down the enzyme in the blood that allows for clotting.

But the same mechanism for which Pradaxa is designed to inhibit also makes the body unable to clot external or internal injuries leading which may lead to serious gastrointestinal side effects including: unusual bruising or bleeding, pink or brown urine, red or black stool, coughing up blood, headaches, bleeding gums, and weakness or swelling in the limbs.

Boehringer Ingelheim advertised this drug to be a safe preventative measure against stroke, but has instead prevented the patients from being able to naturally clot when needed.

Gastrointestinal bleeding is a particular risk for elderly patients taking Pradaxa, because the drug is processed through the kidneys. When the kidneys are unable to process the anticoagulant, the levels of circulation rise considerably and results in a greater risk of the patient suffering gastrointestinal bleeding symptoms.

The risk of gastrointestinal bleeding symptoms is also higher in patients who are taking other drugs associated with internal bleeding risks like aspirin or other anticoagulants.

Overview of Pradaxa Bleeding Risk

The FDA issued a drug safety warning against Pradaxa internal bleeding in December 2011 to warn patients and physicians about the deadly risks and that the drug was being investigated for post marketing problems. Just two years after Pradaxa’s release over 500 patient deaths were reported in association with internal bleeding.

Many critics state that Pradaxa gastrointestinal bleeding symptoms and internal bleeding complications stem from the fact that there was no bleeding antidote to implement in the case of these injuries.

In contrast, Warfarin patients used vitamin K in the case of gastrointestinal side effects and other internal bleeding events.

It was not until recently in 2015 that Boehringer Ingelheim finally released a Pradaxa bleeding antidote, Praxbind, but it came too late to many patients.

Many allege that Boehinger Ingelheim knew of the severity of the risk of gastrointestinal bleeding symptoms, but chose to omit them from the drug’s label to protect Pradaxa’s market value.

Patients affected by Pradaxa internal bleeding injuries could be eligible to file a product liability lawsuit against Boerhinger Ingelheim, and should contact a specialized lawyer.