Pradaxa was developed by Boehringer Ingelheim Pharmaceuticals as an alternative to an existing anticoagulant, Coumadin (warfarin). Pradaxa was advertised to be a superior alternative to Coumadin because patients could take it without changing their diet much or at all, and it did not require much monitoring by a physician.

Like Pradaxa, Coumadin was also linked to internal abdominal bleeding. In the case of Coumadin internal bleeding patients could counteract the side effect by taking itamin K, which allows the blood to clot normally, negating the anticoagulant effects.

Vitamin K does not perform the same function in the case of someone who took Pradaxa. Pradaxa patients were without a similar antidote until the FDA approved Praxbind in 2015–five years after Pradaxa entered the market.

Symptoms of an internal bleed or bleeding problems with Pradaxa include:

• bleeding gums
• bruising without a known cause
• coughing blood
• discolored urine
• frequent nosebleeds
• red or black stools
• vomiting blood

Internal bleeding is a very serious condition, one that many patients do not notice until the bleed becomes severe and exterior symptoms present themselves. In any case, an internal bleed can be hard to stop. Taking the anticoagulant Pradaxa can make it far more difficult to get dangerous bleeding under control.

Before the introduction of Praxbind, patients who suffered a hemorrhage or internal bleed may have had to flush Pradaxa from the person’s system via dialysis, a process which can take hours, requiring multiple blood transfusions. This process is dangerous, lengthy, and sometimes cannot be done in time to save the life of a person experiencing a severe enough internal bleed.

In the three months after Pradaxa was released onto the market, 307 reports of bleeding problems with Pradaxa were filed with the FDA, as well as 260 reports of Pradaxa-related deaths from internal bleeding, gastrointestinal bleeding, stroke, and hemorrhage. This prompted the agency to issue a warning to consumers about the risk of uncontrollable bleeding linked to the use of the drug.

Numerous lawsuits and one class action lawsuit have already been filed against Boehringer Ingelheim, Pradaxa’s manufacturer, over the effects of the drug. Patients claim that the company knew about the risks associated with the drug, and did not notify patients or medical professionals about the risks associated with the drug.

Though all anticoagulants can cause bleeding, patients claim that Pradaxa has such a high risk of bleedings that cannot be stopped easily, that the company should have taken action to warn consumers.

Lawyers are currently investigating consumer reports of internal bleeding problems with Pradaxa (dabigatran), an anticoagulant, or blood-thinning drug. After its FDA approval in 2010, consumers quickly reported that the drug caused a number of serious and possibly fatal side effects.

Bleeding problems with Pradaxa might qualify affected patients to legal recovery.

You may have a legal claim if you or a loved one experienced any of the following Pradaxa side effects:

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