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FDA Launches Pradaxa Bleeding Risk Assessment

FDA Launches Pradaxa Bleeding Risk Assessment

January 14, 2014 — The U.S. Food and Drug Administration (FDA) is launching a new safety assessment of Pradaxa (dabigatran), a controversial new blood-thinner that has been associated with over 500 deaths since it was introduced in 2010. Many experts are concerned because Pradaxa lacks an antidote, which could increase a user’s risk of death from uncontrollable bleeding in an emergency.

The FDA will review pre-existing healthcare data on nearly 100 million people in the Mini Sentinel Pilot Project. They will investigate the rate of intracranial and gastrointestinal bleeding of patients on Pradaxa versus warfarin.

The purpose of the study is to identify patients at higher risk of bleeding on Pradaxa, according to Forbes. Certain patient populations, including older women, have already been linked to a higher risk in some studies.

The study does not investigate patient outcomes. Unlike warfarin, which is reversed with a dose of Vitamin K, Pradaxa has no easy antidote. A recent study published by the Institute for Safe Medicine Practices (ISMP) found that bleeding incidents in Pradaxa patients “were about 5 times more likely than warfarin to result in death (19% versus 4%).”

Despite the growing number of lawsuits, Boehringer Ingelheim defends the safety of Pradaxa compared to warfarin:

“Previous assessments from the Mini-Sentinel pilot, which were published in November 2012 and April 2013, found that bleeding rates associated with new use of Pradaxa do not appear to be higher than those with new use of warfarin…”

Do I have a Pradaxa Lawsuit?

The Schmidt Firm, PLLC is currently accepting Pradaxa injury cases in all 50 states. If you or somebody you know was injured by severe bleeding, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

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