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New Study Casts Doubt on FDA Pradaxa Conclusions
Date:6/25/2013

New York, New York (PRWEB) June 25, 2013

Chaffin Luhana LLP, a national plaintiffs-only law firm, warns heart patients that though the FDA has stated Pradaxa carries no more risk of bleeding than warfarin, a recent study may show evidence that seems to be contrary to the FDA's conclusion.

“Studies have been mixed on Pradaxa,” said Chaffin Luhana LLP co-founder Eric Chaffin, “but the risk is there, particularly because so far, we have no readily available antidote for Pradaxa bleeding. This makes any fall or accident that causes bruising in patients taking Pradaxa potentially deadly.”

According to a report by the dailyRX News Network, in March, at the American College of Cardiology Scientific Sessions, researchers from the University of Illinois at Chicago presented research that showed a high number of bleeding events in those taking Pradaxa (dabigatran) compared to warfarin. (“Does Stroke Rx Cause Excess Bleeding?” dailyRx News, March 18, 2013) The team examined reports of bleeding events submitted to the FDA through 2011-2012. Results showed that Pradaxa was the primary or secondary agent in over 4,000 bleeding events, with 638 fatalities. Warfarin was associated with only a little over 800 bleeding events, with 44 fatalities.

“The total number of bleeding-related fatalities for dabigatran have greatly exceeded warfarin,” the researchers stated. (Kevin McConeghy, et al., “Reports of Bleeding-Related Fatalities with Dabigatran and Warfarin: An Analysis Using the Food and Drug Administration Adverse Events Reporting System,” American College of Cardiology, March 10, 2013)

These results conflict with the FDA perspective recently published in the New England Journal of Medicine. (Mary Ross Southworth, et al.,
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