Pradaxa Bleeding Antidote Announced in Study

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Clik here to view.Researchers may have found an antidote for the Pradaxa bleeding side effects that have reportedly caused hundreds of deaths since the drug’s introduction to the U.S. market in October of 2010.  The popular blood thinner, also known as dabigatran, has led to fatal hemorrhaging for some patients, and thus far there has been no way for doctors to counteract this side effect.

Scientists associated with the drug’s manufacturer, German-based pharmaceutical company Boehringer Ingelheim, outlined the study and its results in a talk given at the AmericanCollege of Cardiology ‘s annual session this past week.

They gave Pradaxa to 30 pigs and subjected them to experiments that caused bleeding.  They then administered the antidote, known as idarucizumab or aDabi-Fab, to 24 pigs, with the 6 additional pigs receiving a placebo.  All those who received the placebo died, while blood loss in the pigs who received the antidote was significantly reduced, resulting in the death of only one-sixth of the pigs.  The results of preliminary testing of aDabi-Fab on rats were also published last year in Blood (the journal of the American Society of Hematology).

Pradaxa bleeding side effects

Pradaxa was first marketed as an alternative to the drug warfarin (marketed as Coumadin). Pradaxa’s main advantage was that while Coumadin required regular blood testing, Pradaxa did not; it was thus marketed as a drug that was far less of a nuisance to prescribe and use.  It was also promoted as a more effective method of stroke prevention.

Unfortunately, there was no antidote to the Pradaxa bleeding (sometimes resulting in “bleed out deaths”), whereas hemorrhaging in Coumadin could generally be reversed with vitamin K.

The FDA received reports of 542 deaths associated with Pradaxa hemorrhages in 2011, and found that the rate of patient death from Pradaxa side effects was five times that of Coumadin in data from 2012. Over 1000 deaths have been linked to Pradaxa at this time.

Pradaxa lawsuits filed against Boehringer Ingelheim

Over 2,000 lawsuits have been filed against Boehringer Ingelheim, accusing the manufacturer of failing to warn doctors and patients about their drug’s bleeding side effects and lack of antidote.  Lawsuits have been consolidated as part of a multidistrict litigation (or MDL) under Judge David Herdon in East St. Louis, Illinois.  (In an MDL, lawsuits with similar complaints against the same defendant are centralized in one court for the pre-trial discovery phase, but will be heard and judged individually.  So called bellwether cases, which will likely set the standard for future verdicts or settlements, are scheduled for September of 2014 and March of 2015.)

In court documents released in early February, internal e-mails raise the possibility that Pradaxa patients may need more frequent blood testing and express concern about the impact this discovery would have on Pradaxa sales.  The company issued a statement that the e-mails represent only “small fragments of the robust discussion and debate that is a vital component in all scientific inquiry, and in the research and development of any important medication such as Pradaxa.”

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