FDA-approved Update to Pradaxa Label May Promote Use

Pradaxa, an anticoagulant drug, is marketed as an effective competitor to Coumadin (warfarin). However, the drug has been linked to serious and potentially deadly side effects, including excessive bleeding resulting from Pradaxa. In the most severe and tragic of cases, families have reported death from Pradaxa bleeding. However, due to an FDA-approved warning label update, Pradaxa use may increase – and so may the number of plaintiffs reporting serious Pradaxa side effects.

Experts call for updated warning against excessive bleeding resulting from Pradaxa

A recent FDA announcement explained that Pradaxa manufacturer Boehringer Ingelheim had been authorized to update the drug’s label to state that it offered superior prevention for certain types of stroke over competitor Coumadin; the update will be included in the “Clinical Studies” label section. The news arrived less than a month after a far less positive finding: that the anticoagulant exhibited a positive link to severe health complications, including excessive bleeding resulting from Pradaxa. In fact, the Quarterly Watch Report from the Institute for Safe Medicine Practices reported that Pradaxa patients had reported more serious complications in 2011 than any other prescription medication. With this news came the recommendation that the drug’s label also be updated to provide a stronger warning against bleeding risk.

FDA-approved update may be based on flawed study results

However, not only does the recently approved change not address the risk of severe hemorrhage; it encourages patients to choose the drug over safer alternatives. The label update is slated to explain that the 150 mg Pradaxa dosage is more effective than Coumadin in the prevention of hemorrhagic and ischemic strokes. The FDA based its approval on the RE-LY clinical study, which was also used to help Pradaxa earn FDA approval in 2010. However, some experts claim the study is flawed, allowing researcher bias and errors to influence the results in Pradaxa’s favor.

Updated label may increase rates of death from Pradaxa bleeding

Despite these concerns, the FDA has allowed Pradaxa to move forward with its label change. If the study’s results are faulty, this could cause serious problems, since many believe that the label update will encourage more patients to take Pradaxa. Additionally, if the FDA does not require label updates regarding the risk of Pradaxa gastrointestinal bleeding and other excessive hemorrhaging, experts are also concerned that the occurrence of side effects, including death from Pradaxa bleeding, will increase. Notably, there is no readily available way to counter Pradaxa bleeding, making these events very serious and often life-threatening.

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