New Study Casts Doubt on FDA Pradaxa Conclusions

Chaffin Luhana LLP warns heart patients that though the FDA has stated Pradaxa carries no more risk of bleeding than warfarin, a recent study questions that conclusion.

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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., “Dabigatran and Postmarketing Reports of Bleeding,” NEJM, April 4, 2013) There, the FDA acknowledged that they had received many reports of bleeding events associated with Pradaxa after the approval of the drug in October 2010—more than those associated with warfarin.

The number of reports conflicted with the controlled trial that supported Pradaxa’s approval, which showed that both drugs “conferred a similar risk of bleeding.” The FDA suggested that the higher number of reports could be due to the fact that Pradaxa was new to the market, as when they used insurance-claim data and administrative data from the FDA Mini-Sentinel database, they “found that bleeding rates associated with dabigatran use during the period of interest did not appear to be higher than those associated with warfarin.”

According to the Institute for Safe Medicine Practices “Quarter Watch,” published January 9, 2013, an analysis of hemorrhage cases for anticoagulant drugs, including Pradaxa, warfarin (Coumadin), and rivaroxaben (Xarelto), Pradaxa bleeding events were about five times more likely than warfarin to result in death. (ISMP “Quarter Watch,” January 9, 2013)

Chaffin Luhana LLP has a long and successful history of protecting the rights of those injured by potentially dangerous drugs like Pradaxa. Partners Eric Chaffin and Roopal Luhana represent high-profile cases in federal and state courts across the country, and provide new online resource centers for clients and the public. To date, Mr. Chaffin and Ms. Luhana along with co-counsel have been involved in recovering over $1 billion for injured consumers. Both have been named to the prestigious New York Metro Super Lawyers list, and though unable to guarantee results, the firm has a distinguished track record of success and is highly committed to each case.

If you or a loved one has suffered an injury after taking Pradaxa, contact Chaffin Luhana LLP for a free and confidential case review at 1-888-480-1123, or visit their website at http://www.chaffinluhana.com.

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CHAFFIN LUHANA LLP
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