Authored by Ned McWilliams
In the first twelve weeks Pradaxa was on the market, more than 300 serious adverse events were reported to the FDA. Within six months of hitting pharmacies and doctors’ sample cabinets, the number of adverse events skyrocketed to more than 900, including over 100 deaths. By December 2011, the number of deaths reported in users of Pradaxa had climbed to over 500. The majority of adverse events involved internal bleeding or hemorrhaging. Taking into account the well-recognized phenomenon of under reporting these figures likely represent just a small fraction of the true number of serious adverse events and deaths caused by Pradaxa side effects.
Doctors, medical researchers and regulators worldwide have now begun to unravel the mystery behind the alarming number of adverse events associated with Pradaxa. Early signs of danger came in a pre-approval clinical trial evaluating its safety and efficacy. The clinical trial that was the basis for FDA approval, The Randomized Evaluation of Long-Term Anticoagulation Therapy (“RE-LY“), compared the safety and effectiveness of Pradaxa and Coumadin. The study reported that Pradaxa was better than Coumadin “in reducing ischemic and hemorrhagic stroke” while the risk of major bleeds was “similar
with Pradaxa and [Coumadin] across major subgroups.” Disturbingly, however, the study also showed that Pradaxa had a higher risk of gastrointestinal bleeding in all patients and a higher risk of all bleeds in patients over 75 years old. Specifically, the study showed that patients on Pradaxa were 50% more likely to suffer a major gastrointestinal bleed.
This all begs the question: why was this drug ever approved? The answer lies in the fact that the makers of Pradaxa claim their drug is more effective than Coumadin, and therefore worth the additional risks of bleeding and the lack of an antidote. This rationale of course assumes that Pradaxa is better than Coumadin. However, the evidence is mounting that this is not the case.