Life threatening bleeding from Pradaxa has been a concern since the drug was released in 2010, with patients discovering there was no readily available reversal agent. Reports of uncontrollable internal bleeding were submitted by patients, alleging the drug had caused them to experience near fatal complications.

Pradaxa and other anticoagulants work by inhibiting the body’s clotting mechanism to increase circulation. These medications are often prescribed to patients suffering from atrial fibrillation and are at high risk for stroke.

However by inhibiting the body’s clotting mechanism, these medications also prevent the body from recovering from serious internal bleeding injuries. This has been allegedly causing patients to suffer life threatening bleeding form Pradaxa.

According to a recent RE-LY clinical study, Pradaxa has caused at least 260 deaths around the world and reported the following rates of serious Pradaxa bleeding complications:

• 16.4% of patients experienced bleeding
• 3.3% of patients experienced serious bleeding
• 1.5% of patients experienced life-threatening bleeding
• 0.3% of patients experienced life-threatening brain bleeding
• 17.4% of patients needed emergency surgery from serious bleeding

The RE-LY study had found that Pradaxa carried a 6% increased risk of serious life threatening bleeding from Pradaxa, and recommended that this problem be the subject of further research.

Overview of Life Threatening from Pradaxa

Manufactured by Boehringer Ingelheim, Pradaxa was the first anticoagulant released in the United States since warfarin in the 1950s. Soon after the release of Pradaxa, other American pharmaceutical companies were inspired to break into the anticoagulant market with the release of Xarelto and Eliquis.

Each of these new generation anticoagulants were advertised to be more efficient than warfarin, and could be prescribed in a single daily dose. While warfarin patients often had to visit their doctors frequently for dose adjustments, there was bleeding antidote in the case of internal bleeding injuries.

Due to the fact that Pradaxa did not have a bleeding antidote for years after its release, reports of life-threatening bleeding from Pradaxa numbered in the hundreds. Boehringer Ingelheim eventually had a Pradaxa bleeding antidote released after the FDA granted Praxbind (idarucizumab) approval on Oct. 16, 2015.

The agency approved Praxbind after successful results were produced from pharmacokinetic and pharmacodynamic studies consisting of 283 subjects. In addition, patients from an ongoing single cohort case series had also shown that Praxbind had almost immediately reversed life threatening bleeding from Pradaxa.

Researchers had found that Praxbind stayed in effect up to 24 hours after administration, which gave the reversal agent accelerated approval from the FDA.

Even though Boehringer Ingelheim managed to produce and release a Pradaxa bleeding antidote, it does not help patients who have already suffered life threatening bleeding from Pradaxa.

Many of these patients have filed legal action against the German pharmaceutical giant, alleging Boehringer Ingelheim failed to notify them about the danger.