San Diego, CA (PRWEB) November 28, 2013
Resource4thePeople announced today its latest consumer update over allegations that the popular blood thinner Pradaxa (dabigatran) may cause irreversible internal bleeding problems.
A recent study funded by the company has produced results that shows scientists are close to finding a method of reversing the effects of the anti-clotting medication, which according to numerous Pradaxa lawsuits* alleging bleeding problems, up to now have been irreversible.
The research was detailed in a Nov. 18 press release** by the drug's manufacturer and detailed in a U.S. News and World Report story*** the same day. The study has not officially been made public because it is preliminary and has not been published in a medical journal yet.
The U.S. News report said "It's easier for patients to take Pradaxa than the older, standard blood thinner warfarin. But unlike warfarin, there's no way to rapidly reverse its action. That can be a life-threatening problem in emergency situations. Doctors have reported cases of patients on Pradaxa who have died after accidents because their blood wouldn't clot."
An independent view of the research and allegations of serious bleeding problems in connection with Pradaxa were contained in the story from a Dutch medical vascular expert who was quoted as saying: "The next step will be actually demonstrating that, for patients who come in with a major bleed with Pradaxa, this does actually improve the outcome."
The inability to reverse the effects of Pradaxa and allegations of bleeding problems are central to the federal lawsuits* from across the country that have been assigned to U.S. District Court Judge David R. Herndon in the Southern District of Illinois. There are now over 1,500 such lawsuits involved.
"We are encouraged by this new research that shows there may be a way of reversing the effects of Pradaxa in order to avoid the life-threatening conditions that are alleged in hundreds of these lawsuits," said Resource4thePeople.
"In the meantime, we will continue to respond to the increased number of inquiries we have been receiving from consumers affected by these allegations by maintaining our policy of offering free consultations about their rights to seek compensation for injuries they may have suffered.
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.”
Resource4thePeople also notes an 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."
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."
*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.