Problems with Pradaxa (dabigatran) have been reported patients ever since shortly after the drug’s approval by the U.S. Food and Drug Administration (FDA) in 2010. Thousands of patients have reported internal bleeding side effects and complications.

Pradaxa became approved as an anticoagulant medication to help reduce risks of strokes and prevent blood clots. However, it was quickly linked with serious complications and injuries. Some of these 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 problems with Pradaxa and any number of injuries associated with the anticoagulant medication, you may be eligible to file a Pradaxa lawsuit.

Overview: Problems with Pradaxa

Pradaxa (dabigtran) was approved by the U.S. FDA as part of a class of medications known as Direct Thrombin Inhibitors. The drug is a relatively new anticoagulant medication that is prescribed to prevent strokes and blood clots in patients with atrial fibrillation. Pradaxa is manufactured by Boehringer Ingelheim Pharmaceuticals.

Although initially believed to be superior to older anticoagulant medications such as warfarin, at the time of its approval by the FDA problems with Pradaxa were quickly reported by hundreds of patients.

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 complications. Even more so, there have been more than 260 alleged death reports connected to problems with Pradaxa. These deaths were caused by complications such as stroke, internal bleeding, and hemorrhaging.

Reversal Agents

Pradaxa was initially believed to be a superior anticoagulant medication as it required less patient monitoring and very little to no change in diet compared to other anticoagulant drugs. However, problems with Pradaxa arose as in comparison to medications that had an antidote to help stop internal bleeding side effects.

Alternate anticoagulant medications, such as warfarin, can counteract internal bleeding complications through the administration of vitamin K. They were thus able to flush and stop internal bleeding complications,

But until Pradaxa’s antidote was approved by the FDA in 2015, patients did not have that safety net. In fact, Pradaxa’s reversal agent was not approved until Oct. 16, 2015, nearly five years after the drug’s approval.

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

The FDA released a notification warning of problems with Pradaxa and its serious internal bleeding side effects in December 2011. Lawsuits filing claims against Boehringer allege that the company new of the risks involved with their drug but failed to notify patients of potential complications.

Most patients taking anticoagulant medications are aware of internal bleeding risks and side effects. But according to plaintiffs in Pradaxa lawsuits, was not made clear was the “excessive” bleeding risks that are associated with Pradaxa.

The filing of a Pradaxa lawsuit may help with a number of damages, including financial repercussions, medical expenses, and time away from work.