DrugNews: Lawsuit Records Show Pradaxa Maker May Have Kept Safety Data From FDA

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So far, 2,139 families have filed a Pradaxa lawsuit alleging internal bleeding, leading to the consolidation of cases in a special federal Pradaxa multidistrict litigation court.

New York, NY (PRWEB) February 27, 2014

The prescription drug safety center DrugNews.net is announcing new information on the site for patients taking the blood thinner Pradaxa. A new report shows the maker of the drug, Boehringer Ingelheim, may have kept safety data from the FDA after it was approved in 2010*.

DrugNews is a free resource providing the latest recalls, safety alerts, research and litigation news to patients taking popular prescription drugs. Visitors can see if others are experiencing similar side effects, avoid potential dangers and decide if they need legal advice.

Pradaxa is a blood thinner approved to prevent blood clots and strokes in patients with atrial fibrillation. Experts disagree, however, whether it increases risks of internal bleeding. The Institute for Safe Medication Practices has advised internal bleeding from Pradaxa could be 5 times as likely to be fatal**.

DrugNews has also added a recent study suggesting patients taking newer blood thinners like dabigatran may be 55% more likely to suffer internal bleeding***. Recently, the FDA launched a new study comparing the internal bleeding and blood clot rates from patients taking Pradaxa and warfarin****.

So far, 2,139 families have filed a Pradaxa lawsuit alleging internal bleeding, leading to the consolidation of cases in a special federal Pradaxa multidistrict litigation court*****. The case is formally known as MDL No. 2385, IN RE: Pradaxa Product Liability Litigation, Southern District of Illinois.

Now, DrugNews has learned that records from the litigation show Boehringer submitted data to the FDA following Pradaxa’s 2010 approval indicating bleeding fatality rates were less than expected, but failed to disclose a different analysis showing higher-than-expected patient bleeding deaths*.

Anyone affected by internal bleeding after taking Pradaxa is encouraged to visit DrugNews.net or speak with a lawyer about their legal options. Due to the specialized nature of federal drug injury cases, DrugNews only recommends lawyers who have already handled Pradaxa lawsuits.

Visit http://www.DrugNews.net today for more information on the research, side effects and litigation news related to Pradaxa and other drugs, or to speak with a lawyer.

*Bloomberg, 2/26/14; bloomberg.com/news/2014-02-25/boehringer-kept-pradaxa-analysis-from-fda-records-show.html
**Institute for Safe Medication Practices, 1/9/13; ismp.org/quarterwatch/pdfs/2012Q2.pdf
***Gastroenterology, July 2013; gastrojournal.org/article/S0016-5085(13)00290-4/fulltext
****Forbes, 1/3/14; forbes.com/sites/larryhusten/2014/01/03/fda-plans-new-safety-assessment-of-dabigatran-pradaxa/
*****JPML, 2/19/14; jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-February-19-2014.pdf


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