There have been several Pradaxa side effects associated with the anticoagulant medication, leading the U.S. Food and Drug Administration (FDA) to raise concerns over the drug’s use as a blood thinning drug.

Prescribed as a blood thinner or anticoagulant medication, Pradaxa (dabigatran) was approved by the FDA to reduce the risk of strokes and blood clots. The drug was manufactured by Boehringer Ingelheim Pharmaceuticals and approved by the FDA in 2010.

However, reported Pradaxa side effects have raised serious concerns because of the drug’s links to causing complications and life-threatening and serious injuries.

Pradaxa Side Effects

There have been a multitude of serious and even life-threatening complications associated with Pradaxa. Some of the reported Pradaxa side effects include:

• Gastrointestinal bleeding
• Heart attack
• Kidney bleeding
• Internal bleeding
• Brain hemorrhage
• Stroke
• Death

Pradaxa is categorized into a class of medications that are known as direct thrombin inhibitors. As part of this class, the relatively new anticoagulant medication acts by inhibiting the thrombin enzyme’s ability to form a blood clot.

Pradaxa was marketed as a superior anticoagulant medication to its competitor warfarin, or Coumadin. This was thought because warfarin required its patients to restrict their diets and undergo frequent check-ins. Pradaxa, on the other hand, did not require such careful monitoring or a significant change in diet.

Complications began to arise with Pradaxa early on. During the first three months following Pradaxa’s approval, the FDA received some 307 adverse event reports linked to Pradaxa side effects.

Critics say many of these episodes of Pradaxa side effects could have been less severe if there had been an available reversal agent for Pradaxa. Whereas Pradaxa was approved by the FDA in 2010, the drug’s reversal agent, Praxbind, wasn’t approved to reverse adverse bleeding side effects until Oct. 16, 2015.

In comparison, a reversal agent for warfarin was provided for patients. Patients could counteract the anticoagulant effects of the medication by taking vitamin K. By flushing out their bodies with vitamin K, patients could counter the abdominal bleeding and allow their blood to clot normally once again. However, for years, patients taking Pradaxa had no remedy to reverse Pradaxa side effects such as the occurrences of life-threatening internal bleeding.

Praxbind (idarucizumab) was approved as Pradaxa’s reversal agent in 2015–nearly five years after Pradaxa’s approval in 2010. Within the first year of Pradaxa’s approval, there had been 260 reported deaths linked to gastrointestinal bleeding, hemorrhage, stroke, and internal bleeding.

The FDA issued a warning of Pradaxa side effects including life-threatening internal bleeding in December 2011. The warning was issued to users of Pradaxa associating the drug with severe internal bleeding side effects. Some symptoms associated with internal bleeding may include discolored urine, coughing up blood, vomiting blood, red or black stools (poop), bruising from unknown causes, and frequent nose bleeds.

A Pradaxa side effects class action lawsuit is filed when several consumers experience the same or very similar injuries associated with the anticoagulant medication. The lawsuit may be filed to seek damages such as time away from work because of injuries suffered, incurred medical expenses, and financial damages.