It is not uncommon for individuals to wonder about possible causes when a parent, aunt or uncle, grandparent or even older sibling has been hospitalized due to internal bleeding.

Older adults may brush off the experience as simply being more “fragile” in old age, but sometimes there may be a direct cause below the surface.

One cause of internal bleeding may be a drug like Pradaxa. There is a plethora of information about the drug’s side effects, which can help elderly family members better understand the medications their doctors have prescribed, including potential drug side effects.

Pradaxa’s Uses and Side Effects

Pradaxa (dagibatran) is an oral anticoagulant medication manufactured by Boehringer Ingelheim Pharmaceuticals. It is used to help prevent the formulation of blood clots in patients who suffer from atrial fibrillation, a type of abnormal heart rhythm

Patients with atrial fibrillation are at risk for stroke because if blood pools and is not properly pumped out of the heart due to the abnormal rhythm, it can clot and then travel to the brain and block flow, leading to a stroke.

Because Pradaxa interferes with the normal clotting mechanism of the body, if a time comes when the blood does need to clot to prevent further bleeding, it is unable to do so. For Pradaxa users, this can lead to internal bleeding. While internal gastrointestinal bleeding is most common, sometimes brain bleeds are reported as well.

Treatment Options for Gastrointestinal Bleeding

An older oral anticoagulant, warfarin, had similar problems with patients suffering from excessive bleeding when they were on the medication. However, a reversal agent was used to successfully stop the bleed and restore the normal clotting in a short amount of time. Intravenous vitamin K and fresh frozen plasma served as an antidote for warfarin.

When Pradaxa was introduced in 2010, it had no antidote, so there was no way to reverse a bleed. The uncontrollable bleeding sometimes led to permanent damage and even fatal consequences. An antidote to Pradaxa, Praxabind, was released in 2015 and will hopefully stop these bleeds in the future, but for many patients, the development came too late.

Research on Pradaxa and GI Bleeds

Two studies on Pradaxa were released in 2014 that shed more light on the safety of the drug. The study published in the journal Circulation looked at over 134,000 patients taking Pradaxa and found that while it decreased the risk of stroke, there was an increased risk of major stomach bleeding and hemorrhage.

The study published in JAMA Internal Medicine looked at 9,300 patients and found that 9 percent of Pradaxa users suffered from major bleeding while only 5.9 percent of the group taking warfarin did.

Pradaxa Litigation

Thousands of injured parties filed lawsuits against Pradaxa’s manufacturer Boehringer Ingelheim. The lawsuits were consolidated into a multidistrict litigation to help streamline the litigation process.

As a result of the lawsuits, Boehringer Ingelheim agreed to pay $650 million to settle over 4,000 active lawsuits that were pending at the time of the settlement, but claimed no wrongdoing despite the large payout.

As more injured parties come forward, plaintiffs have continued to file new Pradaxa lawsuits.

Filing a Pradaxa Lawsuit

If you or a loved one has suffered from gastrointestinal bleeding after using Pradaxa, you may have a legal claim. A Pradaxa attorney can review your case in a complimentary case review and can assist you in understanding the legal options that are available to you based on your situation.