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ISMP Details More Pradaxa Bleeding Reports to FDA

Apr 9, 2012 | Parker Waichman LLP

More bad news this week for Pradaxa.  According to the latest QuarterWatch report from the Institute for Safe Medicine Practices (ISMP), Pradaxa was 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.

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, the maker of Pradaxa said it had received 260 reports of fatal bleeding among Pradaxa patients.

According to the ISMP, most of the serious cases of Pradaxa bleeding submitted to the FDA's Adverse Event Reporting System occurred in people older than 80. 

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. 

In March, bleeding risks associate with Pradaxa were highlighted by an article published in the Journal of Neurosurgery that detailed the death of an 83-year-old Pradaxa patient from a brain bleed that followed a minor fall.   Many of the patients who take Pradaxa are elderly, and such falls are common with this population.

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