San Diego, CA (PRWEB) September 14, 2013
Resource4thePeople announced today its latest update for consumers who may have been affected by allegations that the popular blood thinner Pradaxa may cause internal bleeding problems.
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.
"This is yet another medical study that raises serious concerns about the safety of Pradaxa and these concerns are central to hundreds of Pradaxa lawsuits** alleging serious bleeding problems that now have been consolidated before a federal court judge," said Resource4thePeople.
"As this consolidated litigation proceeds our national network of lawyers is readily available to provide complimentary legal consultations to others who may have been affected by similar bleeding allegations involving Pradaxa."
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.
"In the as-treated analysis, dose adjustment or discontinuation of dabigatran was required in 52 of 162 patients (32%). Ischemic or unspecified stroke occurred in 9 patients (5%) in the dabigatran group and in no patients in the warfarin group; major bleeding occurred in 7 patients (4%) and 2 patients (2%), respectively," the researchers reported. "All patients with major bleeding had pericardial bleeding."
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."
Resource4thePeople also is reporting that the number of Pradaxa lawsuits alleging serious bleeding problems before U.S. District Court Judge David Herndon in the Southern District of Illinois has increased to over 1,500, according to the court file in the litigation.**
The judge recently held a status conference on the litigation in which attorneys for the plaintiffs and those representing the manufacturer of the medication met to brief him on the progress of the cases.
Resource4thePeople will continue to provide updates of this and other litigation involving Pradaxa and will continue to review claims from consumers who have not filed lawsuits.
"The fact is that even though there is a multidistrict consolidation before Judge Herndon in Illinois other consumers are still eligible to file their own Pradaxa bleeding lawsuits alleging the same serious health problems," said Resource4thePeople.
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."
Another important development is the recently announced result of a medical research study presented July 1, 2013 at the Congress of the International Society on Thrombosis and Haemostasis.****
Physicians attending the congress in The Netherlands were told that a study that involved over 23,000 patients showed that those taking Pradaxa (dabigaltran etexilate) as a blood thinner were up to 45% more likely to suffer a heart attack than other patients.
Here was the conclusion of the study as presented to the congress:
“This meta-analysis of RCTs (randomized control trials) provides robust evidence that DE (dabigaltran etexilate) is associated with a significantly increased risk of MI (myrocardial infarction), especially at high dose (150mg bid). No firm conclusion can be taken with the lower DE dose (110mg bid) because of the limited number of studies included in this meta-analysis.
“Health care professionals and regulators should consider appropriate strategy to prevent such serious adverse drug reactions. The limitation of the use of DE in patients at high risk or suffering from coronary heart disease, the concomitant use of aspirin or switching to a FXa inhibitor should be carefully considered.”
Resource4thePeople notes that this finding comes just several months after 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.”
**MDL No. 2385, IN RE: Pradaxa Product Liability Litigation, U.S. District Court, Southern District of Illinois