Updated Pradaxa Bleeding Information: Resource4thePeople Reports Number of Cases Climbs and Comments on New FDA Data Showing Anticoagulant Problems Reporting Frequency

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There are now almost 1,600 cases in the Pradaxa federal multidistrict litigation over allegations of life-threatening bleeding problems. National network of attorneys continues to offer consumers free legal consultations over compensation rights.


Resource4thePeople announced today another update involving allegations that popular blood thinner Pradaxa may cause internal bleeding problems with information about increased numbers of lawsuits* and an independent analysis** of adverse reports to the Food and Drug Administration.

"This is important data for consumers who may have been affected by allegations that the use of the popular anticoagulant Pradaxa can cause life-threatening bleeding problems," said Resource4thePeople.

"As we provide this information we are also announcing that our national network of attorneys will continue to provide free consultations to consumers who may be seeking information about their rights to seek compensation for health problems in connection with these allegations."

The figures* about the increase in the number of federal lawsuits*** that have been consolidated before a federal judge in the Southern District of Illinois show that there are now almost 1,600 cases involved.

The U.S. Panel on Multidistrict Litigation figures from the latest reporting period, Oct. 17, 2013, detail an increase of about 170 from the last reporting period ending Sept. 11, 2013.

"Clearly, the number of cases continues to grow as more consumers come forward with allegations of serious health problems attributed to Pradaxa and we are seeing more consumer inquiries about legal information each month, also," said Resource4thePeople.

Resource4thePeople also notes and independent, non-profit** monitoring medical safety on Oct. 17, 2013 posted figures that showed that the FDA received more reports about side effects about Pradaxa than any other drug the FDA monitors.

The Institute for Safe Medical Practices in its QuarterWatch said that 3,292 reports warning of adverse events, including 582 deaths, were filed over Pradaxa (dabigatran) in 2012.

"For a second straight year dabigatran and warfarin are the most frequently named suspect drugs in direct reports to the FDA.," the authors of the report wrote.

"QuarterWatch has reported on the risks of anticoagulants previously and judged them to be one of the most dangerous of all outpatient drug treatments. The same property that allows anticoagulants to reduce the risk of strokes and blood clots elsewhere in the body leads to high risks for hemorrhage and other bleeding. The result is tens of thousands of emergency room visits or hospitalizations each year."

The main group of federal lawsuits that have been consolidated from cases filed across the country*** have been assigned to U.S. District Court Judge David R. Herndon in the Southern District of Illinois.

Resource4thePeople also notes that other cases continue to be filed in state courts across the country, including five recent cases**** filed in Illinois where plaintiffs are claiming that relatives either died or suffered serious bleeding problems from the use of Pradaxa.

The Madison-St. Clair Record reported***** Sept. 26, 2013 that "Some of the plaintiffs claim their relatives died within months of taking Pradaxa, while others claim chronic bleeding caused by the drug required them to be given blood transfusions to prevent their deaths."

In another Pradaxa development, the recently published findings of a trial that was conducted to determine whether Pradaxa (dabigatran) is an effective alternative to warfarin in patients with atrial fibrillation was terminated because of a high number of bleeding incidents attributed to Pradaxa.

The results of the study****** were published in the Sept. 1, 2013 edition of the New England Journal of Medicine and involved hundreds of patients with mechanical heart valves who were tested in comparisons of the two popular anticoagulants.

The anticoagulant trial was terminated prematurely after the enrollment of 252 patients because of an excess of thromboembolic and bleeding events among patients in the dabigatran group, according to the published findings.

The researchers reached the following conclusion:

"The use of dabigatran in patients with mechanical heart valves was associated with increased rates of thromboembolic and bleeding complications, as compared with warfarin, thus showing no benefit and an excess risk."

Bloomberg News, in a Dec. 11, 2012 posting, reported******* that Pradaxa “has been linked to more than 500 U.S. deaths over a two-year period.”

Bloomberg also reported that “Concerns about Pradaxa’s safety surfaced soon after U.S. doctors began prescribing it. FDA officials said they received reports of 542 deaths and 3,781 side-effect incidents tied to the drug in 2011."

Resource4thePeople notes that the FDA issued a Drug Safety Communication warning Dec. 19, 2012 that the medication should not be used in patients with mechanical prosthetic heart valves.********

Here is a part of that warning:

“The FDA issued a Drug Safety Communication informing healthcare professionals and the public that the anticoagulant Pradaxa should not be used to prevent stroke or blood clots in patients with mechanical heart valves.

“The RE-ALIGN clinical trial in Europe was recently stopped because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin. There was also more bleeding after valve surgery in the Pradaxa users than in warfarin users.”

The court file in the multidistrict litigation*** includes a summation of the Pradaxa allegations:

“All the actions share common factual questions arising out of allegations that plaintiffs suffered severe bleeding or other injuries as a result of taking the drug Pradaxa (dabigatran etexilate) and that defendants did not adequately warn prescribing physicians of the risks associated with Pradaxa, including the potential for severe or fatal bleeding, and that there is no reversal agent to counteract the Pradaxa’s anticoagulation effects.”

***IN RE: Pradaxa Product Liability Litigation, U.S. District Court, Southern District of Illinois, MDL No. 2385

**** Case #s 13-L-469, 13-L-470, 13-L-467, 13-L-468, 13-L-466, St. Clair County Circuit Court, Ill.
***** http://madisonrecord.com/issues/895-product-liability/259488-five-pradaxa-suits-filed-in-st-clair-county#
****** http://www.nejm.org/doi/full/10.1056/NEJMoa1300615
******* http://www.bloomberg.com/news/2012-12-11/boehringer-sued-by-hundreds-over-bleeding-tied-to-pradaxa.html

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