Irreversible Pradaxa Bleeding Side Effects Cited in Death of Texas WomanMay 24, 2012 | Parker Waichman LLP
The daughter of a Pradaxa patient who died of an irreversible brain bleed told the Houston Press that she wouldn't give Pradaxa to a dog after seeing what it allegedly did to her mother.
Since late last year, concerns about Pradaxa’s heart and bleeding side effects have grown, leading some to question whether its risks outweigh its benefits. The Food and Drug Administration (FDA) announced in December that it was conducting a review of Pradaxa safety data after receiving enough reports of brain hemorrhaging and severe gastrointestinal bleeding among patients taking the drug. In November, Boehringer Ingelheim, the maker of Pradaxa, said it had received 260 reports of fatal bleeding among Pradaxa patients.
Bleeding is a common side effect of all blood thinners, including warfarin. However, warfarin bleeding can be stopped with the administration of vitamin K, but there is no similar antidote for Pradaxa bleeding.
The family of Loraine Franklin is suing Boehringer Ingelheim, following their mother's death from an intracranial hemorrhage. Emergency room doctors were unable to stop the bleeding, and it was only then that Franklin, 80, was told that Pradaxa bleeding side effects are largely irreversible. Her family painfully recounted to the Houston Press how hospital staff worked to keep Franklin comfortable, and they watched as her speech became slurred and the blood pooled in her skull.
Franklin passed away just 8 months before she and her husband would have celebrated her 80th wedding anniversary. Her daughters told the Houston Press that they believe Pradaxa robbed them of maybe ten more years with their mother.
Franklin's story is hardly an isolated case. In November, Houston trauma surgeon Bryan Cotton and his colleagues authored a letter in the New England Journal of Medicine that detailed cases of irreversible Pradaxa bleeding.
"Currently, the only reversal option for dabigatran is emergency dialysis (as suggested in a single line in the package insert)," they wrote. "The ability to perform rapid dialysis in patients with bleeding whose condition is unstable or in those with large intracranial hemorrhages will present an incredible challenge, even at level 1 trauma centers."
Last month, the Institute for Safe Medicine Practices (ISMP) reported that Pradaxa had been associated with a total 856 reports of serious, disabling or fatal injury in the second quarter of 2011. Of those, 117 involved deaths that could be associated with serious Pradaxa bleeding.