The Pradaxa bleeding risk has been a prominent concern in the medical community and patient population since the anticoagulant was released in 2010.

Pradaxa, approved by the FDA in October 2010, was the first drug to be approved for blood thinning treatment since Warfarin in the 1960s. However, soon after its release,  it proved to have a major design flaw in the form of uncontrollable internal bleeding.

The Pradaxa bleeding risk was discovered soon after the drug’s release, with the FDA reportedly receiving 307 injury reports within the first three months the anticoagulant was on the market.

These injuries reports consisted of serious injuries including gastrointestinal bleeding. In addition, there were over 260 deaths reportedly caused by uncontrollable Pradaxa bleeding in the drug’s first year of market release.

The Pradaxa bleeding risk eventually spurred the FDA to issue a public warning in December 2011, which warned patients and doctors the anticoagulant could cause uncontrollable internal bleeding.

The FDA issued a later warning in May 2014 alerting consumers that elderly Pradaxa patients faced a greater risk of cerebral bleeding compared to warfarin patients, but no changes were made to the drug’s warning label.

Overview of Pradaxa Bleeding Risk

When Pradaxa was released, it quickly gained popularity with patients because it could be prescribed as a single dose prescription and did not require frequent doctor visits.

In fact, Boehringer Ingelheim had initially determined a bleeding antidote was not necessary for the medication and that hemodialysis could be implemented to remove the drug from the patient’s bloodstream. In contrast, warfarin patients would implement vitamin K to reverse the effects of internal bleeding.

Pradaxa and other anticoagulants work by inhibiting the body’s clotting mechanism, which prevents blood clots from forming. This makes anticoagulant treatment a good option for patients at risk for blood clot attacks, as well as patients who are suffering from atrial fibrillation.

However, this treatment mechanism also impairs the body’s self recovery abilities in minor instances of internal bleeding, which can cause a number of side effects, and quickly become fatal.

Boehringer Ingelehim eventually did successfully get Praxbind, its reversal agent, released in 2015, but Pradaxa patients were without a reversal agent for the first five years the drug was on the market. Praxbind gained full market approval in 2018, which means healthcare providers can now readily use it for emergency Pradaxa situations.

Pradaxa patients should be wary of any signs of internal bleeding, including but not limited to:

• Unusual Bruising or Bleeding
• Blood in Urine
• Blood in Stool
• Coughing up Blood (vomit may look like coffee grounds)
• Headaches, Dizziness, or Fatigue
• Frequent Nose Bleeds
• Bleeding Gums
• Weakness and Swelling in Arms or Legs

Pradaxa patients who experience any of these symptoms should seek medical attention immediately, and talk to their doctor if they have any concerns regarding uncontrollable internal bleeding.

Over 4,000 Pradaxa lawsuits were settled in 2014 that consisted of claims alleging serious injuries from uncontrollable internal bleeding caused by the anticoagulant. Internal bleeding is a potentially fatal complication for Pradaxa patients, however it’s alleged Boehringer Ingelheim failed to properly warn the public.  Pradaxa patients who suffered uncontrollable internal bleeding injuries can still file legal action against the drug manufacturer.