Despite reports of serious Pradaxa side effects such as deadly bleeding, the FDA continues to allow the drug’s manufacturer to market Pradaxa in questionable ways.

Pradaxa is a blood-thinning drug used to help decrease the risk of strokes in patients with atrial fibrillation, manufactured by Boehringer Ingelheim Pharmaceuticals Inc. Introduced in October 2010, Pradaxa was marketed as a more safe and effective alternative over competitor Coumadin (warfarin), an anti-coagulant that had been on the market for over 50 years. However, the FDA has received thousands of reports of patients who suffered from severe Pradaxa side effects, and over 500 incidences of fatal bleeding.

Warfarin patients can monitor the blood-thinning level of the drug and adjust their dose according to need, the most effective of whom maintain a “therapeutic range” and can significantly reduce their risk of stroke. The need for alternative anti-coagulants stemmed from the group of patients outside the therapeutic range.

Pradaxa is marketed as being “35 percent better than warfarin”—but Pradaxa clinical trial data shows that the drug is no more effective than warfarin for the patients who maintain the therapeutic range. The important limitation is only revealed in very fine print in Pradaxa’s marketing.

In addition, Pradaxa’s safety claims have little supporting evidence. Pradaxa’s safety claims are based on the fact that the drug does not contain a black box warning label about serious bleeding side effects, like the label on Coumadin. However, clinical data shows that well-controlled Coumadin users have similar rates of bleeding as Pradaxa users. The FDA issued a Pradaxa bleeding advisory and investigated the drug’s side effects. Last month, the agency claimed that the drug was no more or less dangerous than Coumadin, despite the difference between the drug labels.

More importantly, while the anti-coagulant effects can be stopped in warfarin users with an administration of Vitamin K, there is no simple antidote for Pradaxa users, leading to the increasing incidences of deadly adverse effects.

Patients who suffered from Pradaxa bleeding side effects are filing Pradaxa lawsuits to seek compensation for their injuries. 138 Pradaxa lawsuits are currently underway in a multidistrict litigation in the district court of Southern Illinois. Most recently, Judge David Herndon set forth deadlines for Boehringer Ingelheim to produce evidence in the MDL. To learn more, call (877) 779-1414.

Published November 29, 2012 by