It is widely known that all blood-thinning medications carry a concerning risk: even a minor scrape or cut can quickly lead to an excessive and uncontrollable bleed because the body’s ability to produce coagulate materials is diminished while on the medication. This risk has been present since the introduction of warfarin, the staple in blood-thinning medications for nearly 60 years.
However, marketing materials tout Pradaxa to be just as safe as warfarin, claiming that Pradaxa generally has similar, but lower overall total bleeds than warfarin. However, the clinical trial used to garner FDA approval demonstrated that with Pradaxa there is a higher rate of major GI bleeds as compared to warfarin, and a similar rate of major bleeds. Moreover, there is no reversal agent for Pradaxa like there is for warfarin; meaning that once a major bleed begins, doctors cannot stop the bleed until the drug is removed naturally by the patient’s body, or through dialysis, if the patient is stable enough to receive the treatment.
As a result, lawsuits have been filed against the drug’s manufacturer claiming that patients who took Pradaxa for even a brief period of time were at increased risk for life-threatening bleeds since its levels in the blood are difficult or impossible to assess and bleeds cannot be stopped because there is no known reversal agent. Further, it is alleged that the manufacturer did not warn patients of the irreversible nature of Pradaxa in the “Warnings and Precautions” section of the drugs initial warning label, but instead chose to bury this critical fact in fine print in a section of the label which discusses “Overdosage” on the medicine.
In essence, the Pradaxa lawsuits claim that even if the warning labels were adequate, Pradaxa lacks any benefit sufficient to tolerate the extreme risk posed by the drug—that Pradaxa is dangerous and defective as formulated.