Pradaxa is a commonly prescribed anticoagulant medication that was approved by the U.S. Food and Drug Administration (FDA) in 2010. However, it was quickly found to cause serious adverse effects and complications, including life-threatening bleeding.

Several patients who have suffered bleeding with Pradaxa have filed claims against the manufacturer, Boehringer Ingelheim Pharmaceuticals, alleging they were not adequately warned about the relevant risks.

Additionally, a current investigation is being conducted, with advocates actively researching claims from patients who have suffered from these adverse effects and complications.

In addition to internal bleeding with Pradaxa, some of the other adverse effects and complications include include kidney bleeding, gastrointestinal bleeding, heart attack, stroke, brain hemorrhage and death.

Bleeding with Pradaxa Risks

Pradaxa, manufactured by Boehringer and known generically as dabigatran, is categorized within a class of medications called direct thrombin inhibitors. These are all anticoagulant medications, which can also be termed blood thinners.

In 2010, it was approved by the FDA as an anticoagulant medication allegedly superior to its competitor anticoagulant medication warfarin, also known as Coumadin. Because Pradaxa did not require regular blood monitoring like warfarin does, it was promoted as superior to warfarin.

However, in cases of excessive bleeding, patients who are taking warfarin were able to counteract effects of internal bleeding adverse effects and complications by a doctor administering vitamin K. Vitamin K could stop the effects of warfarin and allow the blood to clot, thereby stopping the internal bleeding.

There was no similar solution, however, for patients who have been prescribed Pradaxa. It wasn’t until 2015, five years after Pradaxa was approved, that an antidote for Pradaxa finally became available.

FDA Reports of Bleeding with Pradaxa

Within the first three months of Pradaxa being on the market, the FDA received 307 reports of patients suffering from excessive bleeding with Pradaxa. Other adverse effects and complications included gastronintestinal bleeding, internal bleeding and other serious problems.

Additionally, 260 reported deaths were reported to the FDA in patients taking Pradaxa. These were due to complications stemming from strokes, gastrointestinal bleeding, internal bleeding and hemorrhaging.

The FDA also issued a warning in December 2011 cautioning patients about these serious risks including uncontrollable internal bleeding.

Bleeding with Pradaxa Lawsuits

There have been several lawsuits filed against Boehringer Ingelheim due to the adverse effects and complications of Pradaxa and the alleged misrepresentation of the risks of the drug to consumers, the medical community and the public at large.

These lawsuits claim that the Boehringer knew of these adverse effects but failed to notify patients and their physicians about the risk of bleeding with Pradaxa.

Although the risks of bleeding is a potential side effect with any anticoagulant medication, Pradaxa lawsuits alleged that Pradaxa has a higher risk of excessive bleeding.

Symptoms of anyone suffering from internal bleeding side effects and complications include, but are not limited to the following: frequent nose bleeds, bleeding from the gums, discolored urine, red or black stool, coughing up blood and possibly vomiting blood.