Many of us at some time in our life will get that phone call that causes sheer anxiety and worry as we learn that a loved one has ended up in the hospital. Elderly loved ones are especially at risk, with the younger generations left trying to make sense of what happened and what they can do to help.

If you’ve had a loved one diagnosed with gastrointestinal bleeding, this article may help to give you a starting point in finding answers.

Gastrointestinal Bleeding and Potential Causes

Gastrointestinal bleeding is internal bleeding that occurs in any part of the gastrointestinal tract, from the esophagus, small intestine, large intestine (colon) to the rectum and anus.

A number of causes can be linked to the development of gastrointestinal bleeding, such as inflammatory diseases, cancers, polyps, hemorrhoids, peptic ulcers and gastritis. However, for some patients, no immediate physical cause is found, and that could lead to the consideration of various medications that may be linked to internal bleeding.

Anticoagulants, also known as blood thinners, are the most common medications linked to internal bleeding events.

Pradaxa and Internal Bleeding

Pradaxa (dagibatran), manufactured by Boehringer Ingelheim Pharmaceuticals, is one of several new generation anticoagulant medications that have been released in the last few  years. Pradaxa is a blood thinner that is commonly used to treat atrial fibrillation, a condition where there is an abnormal heart rhythm that could potentially lead to stroke. It is also used to prevent blood clot conditions such as deep vein thrombosis (DVT) and pulmonary embolism (PE).

Pradaxa works by blocking the normal clotting mechanisms in the blood to reduce the risk of clotting events. It was developed as an alternative to warfarin (Coumadin) which was the medication used for blood thinning purposes for the last six decades. It was intended to be easier to use, and more effective, and for some patients, this has been the case.

Clinical efficacy data related to Pradaxa’s treatment of atrial fibrillation was largely based on the RE-LY study (Randomized Evaluation of Long-Term Anticoagulant Therapy) that compared Pradaxa to warfarin. The study concluded that Pradaxa at 150 mg twice daily was superior to warfarin.

Gastrointestinal Bleeding Treatment

Though warfarin was cumbersome to use with its dietary restrictions and frequent patient monitoring requirements, it was effective and it had a reversal agent readily available to serve as an antidote if internal bleeding got out of control.  Fresh frozen plasma and intravenous vitamin K quickly helped to reverse the effects of warfarin and to stabilize patients needing gastrointestinal bleeding treatment.

For the first five years after its release, Pradaxa had no such antidote to reverse the effects of internal bleeding. Patients were hospitalized and emergency personnel tried to keep patients stable as the effects of the blood thinning medication wore off and the clotting mechanism was restored.

During this time, many patients suffered severe physical damage and even death from the uncontrolled internal bleeding. Fortunately, in the fall of last year the FDA approved an antidote to Pradaxa, called Praxbind. While the antidote will help patients moving forward, earlier patients did not have the ability to benefit from a Pradaxa antidote for gastrointestinal bleeding.

Gastrointestinal Bleeding Lawsuit Information

Many of the earlier patients who were affected, or the families of patients who did not survive, sued the drug’s manufacturer, Boehringer Ingelheim Pharmaceuticals. In 2014, Boehringer Ingelheim reached a settlement to resolve 4,000 Pradaxa lawsuits. Though they admitted no fault, the drugmakers paid out an average of $160,000 to each affected plaintiff.

If you or a loved one has suffered from gastrointestinal bleeding following the use of Pradaxa, you may be entitled to legal compensation for your situation. An experienced attorney will review your case at no charge so you can understand the legal options available to you.