Pradaxa Brain Hemorrhage Risk Lower Than With Warfarin: Study

Amid mounting concerns over the risk of serious bleeding problems with Pradaxa, a new analysis of clinical trial data suggests that users of the newer anticoagulant may face a lower risk of fatal and traumatic brain bleeding, or intracranial hemorrhage, when compared with users of warfarin, or Coumadin.

According to a new study published in the medical journal Stroke, which was funded by Boehringer Ingelheim, the manufacturer of Pradaxa, there were one-third fewer brain bleeding deaths from Pradaxa and less than half of the serious brain bleeding events.

Researchers from McMaster University took a new look at the RE-LY study, which involved 18,113 patients worldwide, for data on how Pradaxa measured up to Coumadin, often known by its generic name warfarin, regarding the rate of intracranial hemorrhages.

The study identified 11 deaths due to intracranial hemorrhages among patients given Pradaxa, compared to 32 deaths with warfarin. That number edged up to 13 deaths when patients were given a standard 150 mg dose of Pradaxa.

There were also 11 patients who took Pradaxa and suffered serious, non-fatal brain bleeding events, compared to 24 among warfarin users. That number stayed the same whether the patients were given 110 mg or 150 mg of Pradaxa.

Pradaxa (dabigatran) was just introduced by Boehringer Ingelheim in the United States in October 2010, and it has become a hot topic within the medical community and among product liability lawyers, as hundreds of deaths have been reported among users of the medication, mostly from bleeding events.

Concerns over bleeding deaths from Pradaxa have sparked safety investigations in the U.S., Europe and Canada, as well as a number of Pradaxa lawsuits filed on behalf of individuals who claim that inadequate warnings were provided about the risks and about the lack of a reversal agent to stop bleeding events when they do occur.

Although Pradaxa was promoted as a superior alternative to Coumadin for prevention of strokes among individuals with atrial fibrillations, complaints allege that Boehringer Ingelheim failed to adequately warn that there is no antidote, or reversal agent. With Coumadin, when bleeding events do occur, they can be counteracted with a dose of vitamin K.

Concerns have also been raised about the RE-LY study, which some claims suggest has fundamental flaws that allowed bias and errors to creep into the results.