Pradaxa (dabigatran) was the first anticoagulant to be approved for clotting prevention since its predecessorwarfarin in the 1950s.

The release of Pradaxa had spurred the release of two other new generation anticoagulants, Xarelto and Eliquis, after the drug brought manufacturer Boehringer Ingelheim.

However at the time the later anticoagulants were released, patients began complaining of serious Pradaxa side effects, including internal bleeding in the stomach.

Approved by the FDA in 2010, Pradaxa was released to be a treatment option for patients with atrial fibrillation and who are at high risk for stroke.

Pradaxa works by inhibiting the body’s clotting ability by dilating the blood vessels to allow for easier circulation, which ultimately prevents blood clots from forming. However, this treatment mechanism also inhibits the body’s ability to recover from basic internal bleeding injuries.

Even though the body can often resolve internal bleeding injuries on its own, including internal bleeding in the stomach, Pradaxa patients need emergency medical treatment.

Pradaxa Internal Bleeding in the Stomach

The risk of gastrointestinal (GI) bleeding, which can occur anywhere between the upper GI tract and the stomach, is a serious risk associated with Pradaxa side effects.

This complication has been most noted in elderly women with impaired kidney function, with the elderly having a generally increased risk of internal bleeding in the stomach. This is because these particular patients face a greater risk of Pradaxa internal bleeding occurrences, especially when the drug is processed through the kidneys.

When the kidneys become unable to process the drug, the patient’s body will have abnormally high circulation levels. Pradaxa patients also face an increased risk of internal bleeding when taking other drugs associated with internal bleeding like aspirin or other blood thinners.

Gastrointestinal bleeding occurs in 50 to 150 people per 100,000 adults every year, with a very high mortality rate. One 2007 study conducted in the United Kingdom, found that 7% of people hospitalized for this condition would later die from their injuries.

Treating gastrointestinal bleeding can be difficult is locating the source of the bleeding, and then stopping the bleeding when the site is hard to reach. Pradaxa patients should be vigilant against signs of gastrointestinal bleeding including:

• Bloody or dark tarry stool
• Large amount of blood passing from the rectum
• Vomiting blood
• Vomiting chunks that resemble coffee grinds
• Anemia
• Low blood count

After receiving hundreds of Pradaxa injury reports, the FDA warned against gastrointestinal bleeding and other Pradaxa side effects in December 2011.

The agency warned the patient population and medical community of the risk of Pradaxa internal bleeding, and that the product was being reviewed for post marketing problems. Even though the problem of Pradaxa internal bleeding events are well known risks now, this warning came too late to many patients.

Pradaxa patients who suffered internal bleeding in the stomach or other bleeding injuries may be able to file legal action. Potential claimants should contact a specialized lawyer to determine if they are eligible for a Pradaxa bleeding lawsuit.