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FDA Issues New Safety Announcement: Increased Risk of Major GI Bleeding with Pradaxa Compared to Warfarin

On May 13, 2014, the FDA issued a Safety Announcement for Pradaxa regarding a recent study finding a higher risk of gastrointestinal (GI) bleeding with Pradaxa compared to warfarin. This information is in follow-up to the FDA’s Drug Safety Communication previously issued on November 2, 2012 regarding the risk of serious bleeding events with Pradaxa.

In the most recent safety announcement, the FDA reports “[i]n its ongoing review of the blood thinner Pradaxa, the FDA recently completed a new study in Medicare patients comparing Pradaxa to the blood thinner warfarin (Coumadin, Jantoven, and generics) for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death…. The new study included information from more than 134,000 Medicare patients, 65 years or older, and found that among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death, than warfarin. The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin. The MI risk was similar for the two drugs.”

Pradaxa is an oral anticoagulant (blood thinner) launched by Boehringer Ingelheim in October 2010. The FDA reports that there have been approximately 6.2 million prescriptions of Pradaxa dispensed from the time of Pradaxa’s approval through December 2013. In particular, the FDA reports that 934,000 patients have received a prescription for Pradaxa from U.S. outpatient retail pharmacies.

According to the Judicial Panel on Multidistrict Litigation, over 2,000 federal Pradaxa® lawsuits are currently pending against the drug’s manufacturers in the United States District Court for the Southern District of Illinois before the Honorable Chief Judge David R. Herndon, and the number of cases is expected to continue to grow. These individuals allege that they have suffered severe – and often fatal – injuries while using Pradaxa® and that Boehringer Ingelheim failed to adequately warn about bleeding risks and the lack of a reversal agent. The first trial in the Pradaxa® Multidistrict Litigation entitled In re: Pradaxa® (Dabigatran Etexilate) Products Liability Litigation (MDL 2385, Case No. 12-md-2385) is set to begin on September 15, 2014 in the United States District Court for the Southern District of Illinois.

The attorneys at Schlichter, Bogard & Denton, LLP represent victims harmed by pharmaceutical manufacturers and have earned an outstanding nationwide reputation by representing thousands of individuals who have suffered serious injuries. If you or a loved one has suffered injuries after using the blood thinning medication Pradaxa®, please contact the attorneys at Schlichter, Bogard & Denton, LLP toll-free at 1-800-873-5297 for your confidential and free consultation.

 

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