By Ned McWilliams

November 26th, 2012  9:00am

Pradaxa, the popular and new blood-thinning medication meant to protect those with atrial fibrillation from stroke continues to generate safety concerns among doctors, patients and international regulators. Despite these growing concerns, the United States FDA has continued its defense of the drug and its decision to approve it – even going so far as to allow Pradaxa’s owner, German pharmaceutical giant Boehringer Ingelheim, to promote the drug in a manner that the FDA has internally stated is of questionable scientific integrity.

Pradaxa was studied and is being marketed in comparison to Coumadin (warfarin) – the standard therapy for preventing strokes in those with atrial fibrillation for more than 50 years. Similar to diabetics monitoring their blood sugar, Coumadin patients monitor the blood-thinning level of the drug and adjust their dose accordingly.

Those who effectively adjust their dose and maintain what is called “therapeutic range” on Coumadin are able to significantly reduce their risk of stroke. Those who are not within therapeutic range are not reducing their risk of stroke – or at least not to the same degree as those within the target range. It was this group of patients – those outside of therapeutic range – that gave birth to the need for alternative medicines – medicines like Pradaxa.

The problem however, is that Pradaxa is being marketed as both safer and more effective than Coumadin. The reason this is a problem is that it simply is not true. When you carefully look at the clinical trial data that served as the basis for approval for Pradaxa, Pradaxa is no more effective than Coumadin when compared to well-controlled Coumadin patients – those who were able to maintain “therapeutic range.” Yet Pradaxa is being marketed as “35% better than warfarin” with only car-commercial-fine-print “notifying” eagle eyed doctors and patients of this important limitation.

Making matters worse – the FDA has allowed the makers of Pradaxa to suggest to doctors and users that Pradaxa is safer than Coumadin. Boehringer Ingelheim is able to do this by pointing doctors to the fact that their product, Pradaxa, does not contain a black boxed warning of serious or fatal bleeding – like that contained on the Coumadin drug label. Boehringer and FDA are doing this despite the same clinical trial data showing no improvement for well-controlled Coumadin patients showing “similar” rates of bleeding in Pradaxa users as seen in Coumadin users.

Bleeding risk is a serious concern with Pradaxa. So serious in fact that after being overwhelmed with reports of serious bleeding in Pradaxa patients, that the FDA was forced to issue a public advisory and assured the American public that it was investigating the matter fully. Last month the same FDA announced the results of their “investigation,” proclaiming that Pradaxa was no more or less dangerous than Coumadin – still ignoring the discrepancy between the two drug labels. Further, independent third parties immediately criticized the methodology employed by the FDA in its investigation – claiming that the results reached were likely little better than random chance.

Unfortunately, doctors and patients continue to be misled about the risks of benefit of this important yet highly dangerous drug. Perhaps the FDA will get it right next time.

More information on Pradaxa dangers.

Neil E. “Ned” McWilliams, Jr. is an associate with the law firm of Levin Papantonio.  His focus is on environmental law, toxic torts and mass tort litigation.