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New Study Examines Pradaxa Internal Bleeding Risks

Manufactured by Boehringer Ingelheim, Pradaxa is promoted as a more convenient alternative to its predecessor warfarin for stroke prevention, as the medication entails less rigorous medical monitoring. Despite this convenience, the anticoagulant, which has no known antidote to quell bleeding events, has been linked to hundreds of injury and death reports. In fact, in 2011 alone, the FDA logged more than 540 deaths attributed to irreversible Pradaxa bleeding. Such serious health risks have prompted litigation against the drug manufacturer, with Pradaxa lawsuits filed on counts of negligence, failure to warn and breach of warranties.

Now, Boehringer Ingelheim has sponsored a new study to evaluate Pradaxa internal bleeding risks, and how they compare to competitor, warfarin. The results of the research, entitled ‘Management and Outcomes of Major Bleeding during Treatment with Dabigatran or Warfarin,’ were recently published in the journal Circulation.

Pradaxa internal bleeding risks investigated in study

The research team, which analyzed records of 1,034 Pradaxa patients who experienced 1,121 major bleeds, compared this data with 27,419 patients given warfarin (brand name: Coumadin) for 6 to 36 months. Participants who were on Pradaxa commonly took anti-inflammatory agents such as aspirin and other non-steriod medications.

The authors of the study concluded that “Patients who experienced major bleeding on dabigatran [Pradaxa] required more red cell transfusions but received less plasma, required a shorter stay in intensive care and had a trend to lower mortality compared with those who had major bleeding on warfarin.”

On the whole, the Boehringer Ingelheim-sponsored study determined that Pradaxa internal bleeding risks seemed to be on par with those associated with warfarin, despite the lack of a reversal agent. While these findings may be encouraging for some patients, others who have suffered uncontrollable gastrointestinal bleeding after taking the blood thinning medication may not be convinced of the drug’s purported safety.

No reversal agent to stop Pradaxa bleeding events

Due to their anticoagulant properties, both warfarin and Pradaxa carry bleeding risks, but those who begin hemorrhaging on warfarin can be given a high dose of Vitamin K to staunch the bleeding, often times saving a patient’s life.

Dabigatran has no such antidote, and once bleeding starts, only a few known treatments can be attempted to prevent an untimely death. Normally, this includes stopping the drug for at least 14 hours until it clears out of the system or administering kidney dialysis to flush Pradaxa out of the body.

Individuals who may suffer a higher risk of Pradaxa bleeding include those:

  • Who suffer kidney problems
  • Are age 70 and older
  • Are underweight or have a low body weight
  • Have stomach bleeding or a history of stomach ulcers
  • Are taking additional blood thinning medications such as Plavix and Effient
  • Are currently taking Heparin-containing drugs
  • Are taking anti-fungal drugs like Nizoral

Pradaxa litigation centralized in federal court

Since its launch in October 2010, Pradaxa has been the subject of dozens of products liability and wrongful death claims against Boehringer Ingelheim. Those who’ve taken legal action argue that the drug manufacturer should be held liable for failing to adequately warn about the dangers of Pradaxa internal bleeding. To better manage the mounting federal cases, the Pradaxa multidistrict litigation (MDL 2385) was established in August of 2012 in the Southern District of Illinois. Overseen by Judge David R. Herndon, the coordinated litigation has already accumulated more than 750 Pradaxa lawsuits, with more expected in the coming months.