DrugRisk Update: Court Docs Show Pradaxa Maker Concerned About Safety Study

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Anyone affected by internal bleeding after taking Pradaxa is encouraged to visit DrugRisk.com or speak with a lawyer about their legal options.

The prescription drug safety advocates at DrugRisk.com are announcing new information on the site for patients who’ve taken the blood thinner Pradaxa. Documents unsealed by a federal judge show the maker of the drug worried an internal safety study might hurt sales if released*.

DrugRisk is a free resource, sharing the latest recalls, safety alerts, research and litigation news with 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 an anticoagulant sold by Boehringer Ingelheim, approved by the FDA in 2010 to prevent blood clots and strokes in patients with atrial fibrillation. Experts disagree, however, whether it increases risks of internal bleeding.

DrugRisk has added warnings from the Institute for Safe Medication Practices that Pradaxa bleeding may be 5 times as likely to cause death**. A recent study also suggested patients taking newer blood thinners including dabigatran could be 55% more likely to suffer internal bleeding***.

Last month, the FDA announced it will conduct a new study to compare the internal bleeding and blood clot rates between Pradaxa and warfarin patients****.

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

Now, DrugRisk has learned documents from Boehringer Ingelheim unsealed by Judge David Herndon show concern that an internal study suggesting Pradaxa patients may benefit from regular blood testing to protect from stroke or internal bleeding could hurt sales if released*.

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

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

*New York Times, 2/6/14; nytimes.com/2014/02/06/business/study-of-blood-clot-drug-pradaxa-unnerved-its-maker-documents-suggest.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/
*****Judicial Panel on Multidistrict Litigation, 2/19/14; jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-February-19-2014.pdf

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