Numerous patients have reported severe Pradaxa internal bleeding side effects and complications said to be the result of taking the anticoagulant medication. Pradaxa is prescribed to help prevent blood clots and to help reduce the risk of strokes.

Pradaxa (dabigatran) was approved by the U.S. Food and Drug Administration (FDA) in 2010. However, it was quickly discovered to cause a variety of serious injuries and complications including Pradaxa internal bleeding.

Some reported side effects have included: gastrointestinal bleeding, heart attack, stroke, brain hemorrhage, death, kidney bleeding, and internal bleeding.

If you or someone you know have suffered from Pradaxa internal bleeding side effects or any number of complications associated with the medication, you may be eligible to file a Pradaxa lawsuit or join in a recent Pradaxa internal bleeding class action lawsuit investigation.

Pradaxa Internal Bleeding

Pradaxa (dabigatran) is a relatively new anticoagulant medication manufactured by Boehringer Ingelheim Pharmaceuticals and is part of a class of drugs known as Direct Thrombin Inhibitors. When initially approved by the FDA, it was thought to be a superior drug to other anticoagulant medications, such as warfarin, as it required less patient monitoring or very little to no change in diet.

However, patients quickly suffered severe side effects including Pradaxa internal bleeding complications. In fact, within the first three months of the drug’s introduction to the market, the FDA received 307 reports of severe internal bleeding complications, gastrointestinal bleeding, and other severe side effects and complications.

Patients discovered that this was because whereas previous anticoagulant medications, such as Coumadin, or warfarin, can counteract internal bleeding complications through the administration of vitamin K, there was no similar antidote provided for those prescribed Pradaxa. Whereas patients taking warfarin could flush and stop anticoagulant effects of the drug through the administration of vitamin K, thereby stopping internal bleeding effects, Pradaxa provided no such antidote.

Within the first year of Pradaxa’s introduction, there have been more than 260 alleged death reports because of Pradaxa internal bleeding side effects. A number of other complications have included events such as undergoing a hemorrhage, stroke, or other internal bleeding side effects.

It wasn’t until Oct. 16, 2015 when the FDA approved Pradaxa’s reversal agent, Praxbind (idarucizumab). There had been no counteract medication to stop Pradaxa internal bleeding side effects and complications since Pradaxa’s approval by the FDA in 2010.

Symptoms of Pradaxa internal bleeding side effects and complications have included frequent nose bleeds, bleeding from the gums, discolored urine, red or black stools (poop), coughing up blood, and possibly vomiting blood.

A warning notification was issued by the FDA of serious Pradaxa internal bleeding risks in December 2011. Lawsuits being filed against the manufacturer claim that Boehringer knew of these serious adverse effects but failed to notify patients of its likelihood.

Additionally, patients taking anticoagulant medications like Pradaxa know of the serious internal bleeding risks involved. Lawsuits claim, however, that Pradaxa has an increased risk of “excessive” bleeding side effects that patients were not properly warned about.

A Pradaxa internal bleeding lawsuit may help recover financial damages, medical expenses, time away for non-work, and even time away to help and care for a loved one that had been prescribed Pradaxa.