DrugNews Update: FDA Orders New Pradaxa Review as Lawsuits Increase

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The most recent court records show the number of cases filed increased nearly 11% from 1,748 on November 18th to 1,936 on December 16th**.

The DrugNews prescription drug safety center has added new information for patients who’ve taken the blood thinner Pradaxa. The FDA has ordered a new review of user data in order to assess the safety of the drug*.

The news comes as court records revealed the number of lawsuits alleging the drug caused internal bleeding grew in December**.

DrugNews is a consumer resource designed to give those taking popular prescription drugs the latest recalls, safety alerts, research and litigation news. Patients can avoid dangerous drugs, see if others are experiencing similar side effects and decide if they need legal advice.

Pradaxa is a blood thinner that was approved by the FDA in 2010 to prevent blood clots and strokes in patients with atrial fibrillation. Experts disagree, however, about whether it increases risks of internal bleeding.

The FDA had previously stated Pradaxa is as safe as traditional blood thinner warfarin***. The Institute for Safe Medication Practices, however, warned that alleged Pradaxa bleeding may be almost 5 times as likely to cause death****. A recent study also suggested patients taking blood thinners like Pradaxa may be 55% more likely to suffer internal bleeding*****.

Now, DrugNews has learned that the FDA will conduct a new study of patient data to assess the rates of bleeding and blood clot events from Pradaxa and warfarin among those with atrial fibrillation*.

Due to the number of patients filing a Pradaxa lawsuit alleging internal bleeding, cases have been consolidated to 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.

The most recent court records show the number of cases filed increased nearly 11% from 1,748 on November 18th to 1,936 on December 16th**.

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

*Forbes, 1/3/14; forbes.com/sites/larryhusten/2014/01/03/fda-plans-new-safety-assessment-of-dabigatran-pradaxa/
**Judicial Panel on Multidistrict Litigation, 12/16/13; http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-December-16-2013.pdf
***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

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