Blood thinner Pradaxa causes gastrointestinal bleeding in some patients, according to recent studies.

Pradaxa was FDA approved in 2010 as an anticoagulant to reduce the chances of a stroke in patients with atrial fibrillation, a type of irregular heartbeat that occurs when or both upper heart chambers function improperly.

Blood clots occur more frequently in people who have atrial fibrillation, increasing their risk of stroke up to five times that of the general population.

While atrial fibrillation itself is not life-threatening, strokes that are due to the condition are more likely to be severe, with a higher incidence of death and disability.

Can Pradaxa Cause Gastrointestinal Bleeding?

While Pradaxa has prevented blood clots from forming, it has also led to gastrointestinal bleeding, such profuse bleeding that patients have died.

Drug manufacturer Boehringer Ingelheim points out that an antidote called Praxbind was introduced in the fall of 2015, but this was too late for people who had already suffered severe, or even fatal, bleeding.

A minimum of 260 patients had fatally bled out after taking Pradaxa by November 2010. The FDA states that Pradaxa is one of the top causes of drug-related adverse events it receives in overall reports.

Before 2012, did not warn that Pradaxa-induced bleeding was irreversible and that no reversal agent was available at that time.

In 2014, the FDA said it found an increased risk of gastrointestinal bleeding with Pradaxa than it did with warfarin.

Pradaxa Claimed Superiority

Pradaxa has been promoted as one of the “new and better” blood thinners because it does not require blood monitoring.

Patients on warfarin need their blood tested periodically to make sure the dose is therapeutic. If the dose is too high, the patient could experience uncontrollable bleeding; too low a dose would leave the patient at risk of blood clots.

While perhaps more convenient than warfarin, Pradaxa is unlikely “safer.”

How Does Pradaxa Cause Gastrointestinal Bleeding?

Pradaxa works by blocking thrombin, a clotting protein. Side effects occur because this clotting protein is not working optimally include bruising, minor bleeding, indigestion and heartburn.

When too much of the clotting protein is prevented from doing its job, gastrointestinal bleeding can be the result.

When Pradaxa causes gastrointestinal bleeding, the symptoms can include:

• Acute bleeding, perhaps with abdominal cramps
• Black or tarry stool
• Vomiting bright red blood
• Dark or bright red blood mixed with stool
• Dizziness or faintness
• Fatigue
• Paleness
• Shortness of breath

In order to be diagnosed with gastrointestinal bleeding, a patient might need a rectal exam, an endoscopy, colonoscopy or lab tests.

Most patients who see Pradaxa cause gastrointestinal bleeding end up in the hospital because blood pressure might drop and the heart rate might increase due to the blood loss. Sometimes, IV fluids or blood transfusions are needed.

Pradaxa Lawsuits

If you or someone you know has taken Pradaxa you have seen Pradaxa cause gastrointestinal bleeding, you could be eligible for compensation through a class action lawsuit.