Reported complications linked to Pradaxa have become a widespread concern throughout the United States, with patients and doctors worried over potentially fatal internal bleeding.

While the recently released bleeding antidote Praxbind helps prevent these internal bleeding incidents from becoming fatal, reported problems with Pradaxa still plague the country. Pradaxa bleeding risks became common knowledge not long after the drug’s release in 2010, when patients began reporting internal bleeding incidents.

According to the FDA, there were 307 internal bleeding incidents in conjunction with Pradaxa prescriptions within its first three months on the market. Within its first years, there were over 260 alleged deaths linked with Pradaxa bleeding incidents including: gastrointestinal bleeding, hemorrhage, and stroke.

Before Praxbind was released, the only way patients could be treated from internal bleeding was undergoing dialysis to flush the medication from their bloodstream. This treatment takes hours to conduct, with patients often forced to undergo blood transfusions.

The FDA eventually warned the public against these problems with Pradaxa in December 2011, stating the medication could potentially induce uncontrollable internal bleeding. The FDA issued this warning after over 2,300 patients reportedly developed Pradaxa internal bleeding incidents, which made doctors concerned that this medication is unreasonably dangerous to patients.

Numerous critics at the time complained that Pradaxa should not be available for patients because it lacked a bleeding antidote. While this is not the case now, the problems with Pradaxa still include potentially fatal internal bleeding incidents.

Overview of Pradaxa Bleeding Problems

Before Pradaxa was released, warfarin was the main anticoagulant of choice on the market and has been around for decades. Anticoagulants work by inhibiting the body’s clotting mechanism, which will increase the efficiency of the body’s circulation system.

These drugs are frequently prescribed to patients suffering from atrial fibrillation, who are at high risk for blood clot events are often prescribed these medications. However, their treatment mechanism also inhibits n the body’s ability to recover from internal bleeding incidents.

When Pradaxa was released, it quickly overtook warfain in popularity for its feature of single dose prescriptions. Unlike warfarin, Pradaxa patients did not have to frequently see their doctors for dose adjustments.

However, warfarin also had an established reversal agent in the form of vitamin K, in the case of internal bleeding incidents. Pradaxa patients should be wary of any signs or symptoms of internal bleeding including:

• Unusual Bruising or Bleeding
• Pink or Brown Urine
• Red or Black Stool
• Coughing up Blood
• Headaches and Fatigue
• Bleeding from Gums
• Frequent Nose Bleeds
• Weakness and Swelling in Arms and Legs

Manufacturer Boehringer Ingelheim has faces thousands of product liability claims related to Pradaxa, leading to a large settlement in 2014.

This settlement resolved a large number of Pradaxa lawsuits. Each of these Pradaxa lawsuits alleges the pharmaceutical company failed to adequately warn the plaintiff against potentially fatal internal bleeding. As more patients suffer bleeding injuries while on Pradaxa, the manufacturer will most likely continue to face product liability claims regarding problems with Pradaxa.