Numerous patients have reported serious gastrointestinal bleeding, allegedly as a result of taking the blood thinner Pradaxa (dabigatran)

Gastrointestinal bleeding injuries can pose life-threatening dangers to the patients, often requiring hospital intervention to reverse the effects.

Often prescribed to patients suffering from atrial fibrillation or at high risk for stroke, this drug’s treatment mechanism would ideally prevent blood clotting. Pradaxa is manufactured by Boehringer Ingelheim, and was approved for the United States market in 2010.

Pradaxa was the first medication to be released for anticoagulant purposes since Warfarin in the 1960s. It was advertised to be a superior and more convenient alternative to Warfarin, as Warfarin requires frequent dose adjustment and frequent doctor appointments.

The appeal of Pradaxa’s promises included being prescribed in one dose, while working faster and more efficiently than Warfarin. The later release of new anticoagulants Xarelto and Eliquis decreased Pradaxa’s popularity, but it still maintained a significant following in the patient population.

Gastrointestinal Bleeding Injuries

Unfortunately, these new anticoagulants shared the same problem of causing serious gastrointestinal bleeding and other internal bleeding complications. Gastrointestinal bleeding is a spontaneous internal bleeding injury that occurs somewhere along the patient’s gastrointestinal tract.

Compared to to Warfarin, which uses vitamin K as a stopping agent in these cases, the new anticoagulants had no reversal agent. It was not until late 2015 that Praxbind was developed and approved as Pradaxa’s bleeding antidote.

Gastrointestinal bleeding occurs in 50-150 per 100,000 adults per year, and comes with a very high rate of mortality. One study from the United Kingdom found that seven percent of patients who were hospitalized for serious gastrointestinal bleeding died from the complication.

Medical intervention is vital in preventing deaths from these bleeding injuries, with physicians encouraging patients to be vigilant for any gastrointestinal bleeding symptoms.

It can be difficult for physicians to treat gastrointestinal bleeding, due to the long length of the gastrointestinal tract. However, the location could be determined based on the gastrointestinal bleeding symptoms the patient suffered.

One of the most common side effects of this injury is bloody stools; the bright color of blood can indicate the bleeding site is somewhere on the lower gastrointestinal tract.

Other gastrointestinal bleeding symptoms patients should look out for include:

• Dark or Gray Colored Stool
• Coughing or Vomiting Blood
• Dark Colored Vomiting
• Anemia
• Unusual Bruising or Bleeding
• Bleeding Gums or Frequent Nose Bleeds
• Weakness or Swelling in Arms, Hands, Feet, or Lower Legs

Overview of Pradaxa Bleeding Risks

For years, numerous patients were at risk for uncontrollable bleeding injuries that often required hospital intervention to fix. In December 2011, after reviewing post-market studies, the FDA issued a published warning regarding Pradaxa internal bleeding risks, such as gastrointestinal bleeding.

The federal agency indicated that while bleeding risks were common between all blood thinners, it was evaluating whether or not Pradaxa was unreasonably dangerous to patients. Boehringer Ingelheim has been repeatedly criticized for hiding the risk of serious gastrointestinal bleeding, and for exaggerating the benefits of Pradaxa.

In May 2014, Boehringer Ingelheim reached a massive settlement amount of $650 million to settle thousands of Pradaxa bleeding lawsuits. Former or current Pradaxa patients who suffered internal bleeding may be able to file a claim to recover medical damages they suffered.