DrugRisk Safety Update: FDA Plans New Study of Blood Thinner Pradaxa

Share Article

The DrugRisk Center is the largest source on the Web for information on prescription drug research, side effects and legal news. Visit http://www.DrugRisk.com

News Image
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 medication safety advocates at DrugRisk.com have added new information for those who have taken the blood thinner Pradaxa. The FDA recently ordered a new study of patient data in order to determine the safety of the drug*.

DrugRisk is a free consumer resource designed to improve patient safety by sharing the latest recalls, safety alerts, research and litigation news on popular prescription drugs. Visitors can avoid dangerous drugs, see if others are experiencing similar side effects and decide if they need legal advice.

The blood thinner Pradaxa was approved by the FDA in 2010 for treatment in preventing 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 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, DrugRisk has learned that the FDA plans to conduct a new study of patient data to compare the occurrence rate of internal bleeding and blood clots in atrial fibrillation patients taking Pradaxa and warfarin*.

A number of patients have also filed a Pradaxa lawsuit alleging internal bleeding, leading to 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. The latest court records show 1,936 cases filed as of December 16th*****.

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.

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

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Chris Schroeder
+1 888-415-1859
Email >
Visit website