It’s disturbing to note that this study had to be halted early because of the high rates of Pradaxa side effects, including internal bleeding.
New York, New York (PRWEB) September 08, 2013
As Pradaxa lawsuit (http://www.pradaxalawsuithelp.com/) claims continue to move forward in courts around the country, Bernstein Liebhard LLP notes that a newly-published study has reported that Pradaxa is no safer or effective than warfarin when used to treat people with mechanical heart valves. The study, called RE-ALIGN, was halted early after it became apparent that Pradaxa patients were more likely to suffer thromboembolic events, including strokes, heart attacks and blood clots, as well as internal bleeding, compared to those treated with warfarin, a blood thinner that has been on the market for decades. The study appears in the September 1, 2013 issue of the New England Journal of Medicine.*
“It’s disturbing to note that this study had to be halted early because of the high rates of Pradaxa side effects, including internal bleeding. This research is just another reminder that the risks and benefits of Pradaxa need to be more fully evaluated,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is currently offering free Pradaxa lawsuit evaluations to patients who suffered serious internal bleeding while using this blood thinner.
Pradaxa, which is used to prevent strokes in people with a heart-rhythm disorder known as atrial fibrillation, was approved by the U.S. Food & Drug Administration (FDA) in October 2010. In December, shortly after the RE-ALIGN trial was halted, the FDA announced that a new contraindication was being added to the Pradaxa label to warn against its use in patients with mechanical heart valves.
According to a report from Bloomberg.com, Pradaxa was touted as an improvement over warfarin, a blood thinner sold under the brand name Coumadin. However, unlike warfarin, there is no readily available antidote to stop Pradaxa bleeding.** According to the Institute for Safe Medicine Practices (ISMP), an analysis of hemorrhage cases reported to the FDA during the second quarter of 2012 found that Pradaxa bleeding is 5 times more likely to result in death compared to warfarin bleeding.***
According to court documents, more than 1,470 Pradaxa lawsuits have been filed in a multidistrict litigation underway in U.S. District Court, Southern District of Illinois on behalf of alleged victims of Pradaxa bleeding. All of the complaints accuse Boehringer Ingelheim of selling the blood thinner despite knowing it could cause fatal bleeding in some patients, and failing to adequately warn that there was no readily-available antidote for Pradaxa bleeding. (In Re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation – MDL No. 2385)
Alleged victims of Pradaxa bleeding may be entitled to compensation for their medical bills, lost wages, pain and suffering and more. Read More about Pradaxa side effects at Bernstein Liebhard LLP’s website. To arrange for a free legal consultation, please call 800-511-5092.
*nejm.org/doi/full/10.1056/NEJMoa1300615, NEJM, September 1, 2013
**bloomberg.com/news/2012-12-11/boehringer-sued-by-hundreds-over-bleeding-tied-to-pradaxa.html, Bloomberg.com, December 11, 2012
***ismp.org/quarterwatch/pdfs/2012Q2.pdf, QuarterWatch, January 2013
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past 10 consecutive years.
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Bernstein Liebhard LLP
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