Pradaxa is a popular blood thinner manufactured by one of Germany’s largest pharmaceutical manufacturers, Boehringer Ingelheim.

In recent studies, however, it has been linked to dangerous side effects such as Pradaxa uncontrollable bleeding, which can have fatal consequences.

The drug was approved by the Food and Drug Administration, or FDA, in 2010, and it was mainly manufactured and prescribed to prevent blood clots from occurring in patients suffering from atrial fibrillation or abnormal heart rhythm.

Pradaxa quickly became one of the top prescribed drugs with revenue topping $1.2 billion in 2014, and in comparison to older anticoagulants, both doctors and patients had raved of the drug’s effectiveness and convenience.

It is well known that there is a risk of internal bleeding when taking any blood thinner, but in the case of Pradaxa uncontrollable bleeding, however, it has been alleged as the primary cause of death for some. This has led several patients to deliberate extensively if Pradaxa is the right drug for them.

Symptoms of Pradaxa uncontrollable bleeding can include excessive or unexplained bruises, swollen or painful joints, weakness or fainting, bloody urine or stools, small red or purple spots under the skin, coughing fits that produce blood, vomit or a substance that looks like coffee grounds, unusually heavy menstrual bleeding, or abnormal bleeding from the nose, mouth, vagina, or rectum.

Pradaxa was the first drug manufactured in a new class of anticoagulant medications known as the NOACs, or novel oral anticoagulants.

Eliquis, manufactured by Pfizer and Bristol Myers-Squibb, and Xarelto, manufactured by Bayer, are also a part of this class.

Typically, anticoagulant medications prevent blood clots and strokes by reducing vitamin K levels in the bloodstream. The drug achieves similar results but through a different process.

Instead of decreasing vitamin K levels, Pradaxa inhibits the enzyme thrombin, an enzyme responsible for forming blood clots. By blocking thrombin, the body is prevented from forming clots.

Furthermore, patients who taking Pradaxa do not have to follow a special diet by avoiding foods that are high in vitamin K, and they do not have to visit their doctor for frequent monitoring or submit to regular blood tests as with warfarin.

To try and prevent the alarming death rate that was taking place in patients taking Pradaxa due to Pradaxa uncontrollable bleeding, an antidote, Praxbind, was formulated. It was approved by the FDA in 2015, but this did not help others who suffered from internal bleeding the first five years after Pradaxa was released.

Not long after it approved Pradaxa, the FDA began receiving numerous reports that patients had suffered from internal bleeding incidents.

Rates indicate that Pradaxa had led to more than 500 patient deaths suffering from Pradaxa uncontrollable bleeding.

Accordingly, between 2010 and 2015 it was precisely because there had not been an antidote for the drug that was approved by the FDA that these bleeding events were excessively dangerous, critics claim.

Internal bleeding for patients taking warfarin could be controlled by administering vitamin K, but for those prescribed Pradaxa, there was not a safe way to do so.

As there was no antidote for Pradaxa, doctors attempted to clear Pradaxa from a patient’s bloodstream by using dialysis. However, this intervention typically only worked remove about 60% of the circulating levels of Pradaxa in the body, which was not always enough to have a positive effect.

The antidote Praxabind works by neutralizing the effects of Pradaxa. However, it is not effective for patients who have taken other blood thinners, even other NOACs Eliquis and Xarelto.