Internal bleeding and Pradaxa (dabigatran) have had a troubling correlation since the drug’s release in 2010, with numerous patients reporting uncontrollable bleeding incidents.

According to the FDA, there have been 307 reports of internal bleeding and Pradaxa, with each of the patients needing emergency medical treatment. In addition, within the first year of its market release, there was 260 deaths reported allegedly connected with internal bleeding and Pradaxa.

This report came from the Institute for Safe Medication Practices, with researchers finding that Pradaxa exceeded 98.7% of other drugs in injury reports, compared to other medications the institute was monitoring.

Further research has also indicated that gastrointestinal bleeding is a significant risk with the internal bleeding and Pradaxa correlation. A study found:

• 16.6% of patients may experience Pradaxa internal Bleeding
• 3.3% of patients may experience serious Pradaxa internal bleeding
• 1.5% of patients may experience life threatening Pradaxa internal bleeding
• 0.3% of patients may experience Pradaxa brain hemorrhage or stroke

Researchers have found that the risk of Pradaxa internal bleeding may be especially prevalent in elderly patients with kidney problems, or if the patient is taking other medications with internal bleeding problems.

The FDA issued a pubic safety warning in May 2014 regarding internal bleeding and Pradaxa, specifically addressing the potential for gastrointestinal bleeding. The agency released this warning after reviewing a study that observed over 134,000 Medicare patients, with researchers finding that Pradaxa had been connected with gastrointestinal bleeding.

The concern about Pradaxa and internal bleeding has been prevalent since 2010, with the FDA stating the medication has been prescribed over six million times to 934,000 patients from 2010 through 2013.

Overview of Pradaxa Internal Bleeding Complications

Pradaxa is a new generation anticoagulant that was approved to be a treatment option for patients suffering from atrial fibrillation, which puts them at high risk for stroke.

Manufactured by Boehringer Ingelheim, Pradaxa was the first medication to be released for blood thinning purposes since warfarin (Coumadin) in the 1960s. Since its release, two other new generation anticoagulants, Xarelto and Eliquis, have followed and have become intense competition for each other.

Pradaxa quickly overtook warfarin in popularity after its release, due to patients being able to have a single daily dose prescription. While warfarin worked well for many patients, they had to attend frequent doctor visits for blood testing and dose adjustments.

Pradaxa and other new generation anticoagulants could be prescribed in single doses, and Pradaxa was touted as a more convenient option. However, until just a couple years ago, Pradaxa did not have a reversal agent in the case of internal bleeding complications.

Paradaxa and other similar anticoagulants work by inhibiting the body’s clotting mechanism and improving overall circulation, However, this also prevents the body from being able to recover from minor internal bleeding injuries. Should warfairn patients ever need a reversal agent, doctors simply need administer vitamin K.

Pradaxa did not have this safety feature until 2015, after the antidote Praxbind was approved by the FDA. Now patients can receive a bleeding antidote in the emergency room should they suffer any injuries relating to internal bleeding and Pradaxa.

The new antidote did not help patients who had already suffered Pradaxa internal bleeding injuries. Patients who incurred damages from internal bleeding and Pradaxa may be able to file legal action against Boehringer Ingelheim.