DrugRisk Update: Pradaxa Maker Seeks Approval for Additional Uses of Drug Despite Growing Lawsuits

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The FDA has advised Pradaxa is no more dangerous than traditional blood thinner warfarin.

The prescription drug resource center DrugRisk.com is announcing new information on the site for patients taking the blood thinner Pradaxa. Despite growing lawsuits and studies alleging the drug may have internal bleeding risks, the maker is seeking FDA approval for increased use*.

The DrugRisk resource center provides those patients taking popular prescription drugs with the latest warnings, recalls, studies and legal news. Visitors can see if others are experiencing similar side effects and decide if they need legal advice.

Pradaxa is a blood thinner approved by the FDA in 2010 as a stroke preventative for patients with atrial fibrillation. Experts disagree, however, about its risks for internal bleeding. The FDA has advised Pradaxa is no more dangerous than traditional blood thinner warfarin**.

Others, like the Institute for Safe Medication Practices, have warned that patients may be nearly 5 times as likely to die from Pradaxa bleeding than from bleeding with warfarin***. A study this year from the Netherlands also suggests patients taking newer blood thinners like Pradaxa may be 55% more likely to suffer internal bleeding****.

A growing number of patients have also filed a Pradaxa lawsuit alleging internal bleeding, leading to the consolidation of cases in a special federal multidistrict litigation court in Illinois. The case is formally known as MDL No. 2385, IN RE: Pradaxa Product Liability Litigation, Southern District of Illinois. Latest court records show the number of cases filed has increased from 1133 on July 10th to 1389 on August 15, a rise of over 22%*****.

Now, the maker of Pradaxa, Boehringer Ingelheim, has petitioned the FDA for approval to market the drug not only to those with atrial fibrillation, but also as a treatment for deep vein thrombosis and pulmonary embolism*.

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

*Bloomberg News, 8/28/13; businessweek.com/ap/2013-08-28/boehringer-ingelheim-seeks-new-approval-of-pradaxa
**FDA, 11/2/12; http://www.fda.gov/Drugs/DrugSafety/ucm326580.htm
***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
*****Judicial Panel on Multidistrict Litigation, 8/15/13; jpml.uscourts.gov/sites/jpml/files/Pending_MDL-Dockets_By_District-August-15-2013.pdf

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Chris Schroeder
DrugRisk
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