Pradaxa (dabigatran), an anticoagulant medication prescribed to treat and prevent the risks of blood clots and strokes, has been linked to adverse risks and complications, according to blood thinner safety studies.

Pradaxa was reported to have caused a multitude of serious and life threatening injuries following its approval by the U.S. Food and Drug Administration (FDA) in 2010.

Some reported side effects that have been cause for concern about Pradaxa’s blood thinner safety include kidney bleeding, internal bleeding, heart attack, brain hemorrhage, gastrointestinal bleeding, and death.

Pradaxa Risks and Blood Thinner Safety

Pradaxa is a relatively new anticoagulant medication manufactured by Boehringer Ingelheim Pharmaceuticals. It is prescribed to reduce the risks of developing strokes and blood clots.

Pradaxa is categorized into a class of drugs termed direct thrombin inhibitors. The drug limits thrombin’s ability to form a clot.

There are multiple ways a blood clot can form. For example, when a heart does not beat as regularly as it should, it is unable to pump blood throughout the body as effectively. Blood can then pool in the upper chambers of the heart, known as the atria, and this pooling can cause a blood clot to form. If the clot in the heart breaks away and travels directly to the patient’s brain, it can cause a stroke to occur.

With Pradaxa’s approval by the FDA in 2010, it was quickly believed to be a superior anticoagulant to another drug, warfarin, also known as Coumadin.

This was believed to be the case because while warfarin required periodic patient monitoring and diet restrictions, Pradaxa does not require watchful supervision and not even a change in patient diet.

However, whereas warfarin has always had a reversal agent that can reverse the effects of the anticoagulant medication, Pradaxa’s reversal agent, Praxbind, was not made available to patients until Oct. 16, 2015.

Warfarin patients who wanted to counteract the drug’s anticoagulant effects could simply take vitamin K. But for years, patients taking Pradaxa had no pharmaceutical remedy that could reverse occurrences of continuous and life-threatening internal bleeding.

Praxbind (idarucizumab) became approved as Pradaxa’s reversal agent in 2015, five years after Pradaxa’s approval in 2010. Before then, no counteracting medication had been made available to patients that could limit internal bleeding side effects.

In fact, within the first three months of Pradaxa’s approval, the FDA received 307 adverse event reports filed by patients taking Pradaxa, raising issues of blood thinner safety. An additional 260 death reports were also filed with the FDA.

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

A safety warning announcement was issued by the FDA in 2011, advising Pradaxa users about serious internal bleeding side effects.