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New Research Points to Risks of Pradaxa Brain Hemorrhage

Emerging research underscores the potentially fatal consequences of Pradaxa bleeding complications.

The blockbuster anticoagulant was launched by drug maker Boehringer Ingelheim back in October 2010, but the lack of a Pradaxa reversal agent has resulted in hundreds of deaths among recipients, as doctors have few means to stop the effects of uncontrolled bleeding brought on by the medication. This month, two new studies highlight the dangers of intracranial Pradaxa brain hemorrhage among patients who suffered closed head injuries. The research was published in two respected medical journals: Neurosurgical Focus and the Journal of Neurosurgery.

Dr. Brian Walcott, who co-authored one of the studies said, “[Pradaxa] has the potential to provide an important health benefit when used for the proper indications… The lack of an available reversal agent should be recognized as an important current limitation of its use, particularly in patients at a high risk for falls.”

Study reveals dangers of Pradaxa brain hemorrhage

In the Journal of Neurosurgery report, researchers compared case studies among head trauma patients who were on the older blood-thinning medication known as warfarin with patients who took Pradaxa (dabigatran) and others who took no anticoagulants. The study included 15 patients who suffered closed head injuries. Those who were taking warfarin recovered, but of the five patients who were on Pradaxa, two of them died due to brain hemorrhaging that physicians were unable to control, due to the lack of reversal agent. Bleeding events associated with warfarin, on the other hand, can be staunched with a dose of Vitamin K.  The team of researchers concluded that “The development of reversal agents is urgently needed given the growing number of patients treated with this medication.”

Pradaxa bleeding complications in patients have led to uncontrollable gastrointestinal (GI) hemorrhages and strokes, prompting scores of lawsuits around the nation. Plaintiffs and the families of those who died from Pradaxa-related bleeding injuries, claim that manufacturer Boehringer Ingelheim failed to properly test the medication before marketing it, and failed to warn consumers about potential risks. The Food and Drug Administration (FDA) has been flooded with adverse event reports involving Pradaxa bleeding events.

In the first quarter of 2011, the agency reported that some 120 people died on Pradaxa and 500 or more patients suffered complications with incidents of Pradaxa hemorrhage or bleeds. These figures are a stark contrast to those associated with warfarin – a drug that requires patients to undertake more frequent monitoring, but has fewer risks of excessive bleeding.

The other study reported in Neurosurgical Focus examined methods and potential reversal agents that could be used to prevent Pradaxa blood thinning effects.  Researchers discovered that the only viable means to mitigate these effects was to administer dialysis on patients to cleanse the blood and remove all traces of the drug from the system.

Pradaxa bleeding complications spark wrongful death claims

Though still widely prescribed for patients with atrial fibrillation, adverse Pradaxa side effects have prompted a wave of litigation among individuals who suffered life-altering injuries and complications from the blood-thinning medication. Plaintiffs allege that Boehringer failed to sufficiently alert them about the risks of complications such as Pradaxa brain hemorrhage.

To coordinate pre-trial proceedings, all federal cases alleging Pradaxa bleeding injuries were centralized in U.S. District Court for the Southern District of Illinois, where Boehringer Ingelheim faces hundreds of claims.  Judge David Herndon is overseeing the MDL and has scheduled the first trial dates for August 2014. However, both parties will be meeting this August to begin discussions for possible Pradaxa lawsuit settlements.