Any bleeding from Pradaxa is potentially serious because there is no effective antidote to stop Pradaxa hemorrhaging.
New York, NY (PRWEB) April 02, 2012
Parker Waichman LLP, a national law firm representing the victims of defective drug side effects, is warning that life-threatening Pradaxa bleeding events may follow a minor trauma, such as a fall that results in a seemingly non-serious head injury. According to Parker Waichman LLP, any bleeding from Pradaxa is potentially serious because there is no effective antidote to stop Pradaxa hemorrhaging. The firm is currently evaluating potential lawsuit claims on behalf of victims who suffered serious Pradaxa bleeding side effects, including intracranial hemorrhage (brain bleeds), after falls and other minor traumas.
Pradaxa, approved by the U.S. Food & Drug Administration (FDA) in October 2010, is a blood thinner known as a direct thrombin inhibitor. It is approved to reduce the risk of stroke and blood clots (systemic embolism) in patients with non-valvular atrial fibrillation. According to the FDA, from October 2010 through August 2011, a total of approximately 1.1 million Pradaxa prescriptions were dispensed and approximately 371,000 patients received Pradaxa prescriptions from U.S. outpatient retail pharmacies. [fda.gov/Drugs/DrugSafety/ucm282724.htm]
All blood thinners pose a risk of serious, potentially fatal bleeds. According to the FDA, in a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs. However, Parker Waichman LLP points out that bleeding with warfarin can be stopped with the administration of vitamin K, while there is currently no practical, effective antidote for Pradaxa bleeding.
In March 2012, a case study published in the Journal of Neurosurgery detailed one incident where an 83-year-old Pradaxa patient died as a result of intracranial bleeding within hours following what was characterized as a "ground-level" fall. The patient, who had been taking 150-mg twice-daily Pradaxa for new-onset atrial fibrillation for one month before the accident, was alert and responsive with a normal neurological exam when he was admitted to the ER. An initial CT scan showed small, superficial areas of hemorrhage in his right temporal lobe and left temporal and parietal lobes.
Within two hours, however, the patient developed slurred speech and his neurological state began to deteriorate rapidly. Additional scans also revealed that the bleeding in his brain was growing significantly worse. Despite treatment with a drug called recombinant factor VII, the patient continued to deteriorate rapidly as bleeding spread across most of the left hemisphere of his brain in just six hours. Dialysis can remove 35% to 60% of circulating Pradaxa in two to three hours, but wasn't considered until too late to be effective for the reported case.
According to a report from Newsinferno, Boehringer Ingelheim confirmed last November that it had received 260 reports of fatal bleeding among Pradaxa patients. The number of Pradaxa deaths was five times higher than what Boehringer Ingelheim reported earlier that month, when the company said it had tallied 50 deaths from serious bleeding worldwide among patients taking Pradaxa, Newsinferno said.
According to a report from Public Health Watchdog, the FDA announced in December 2011 that it had launched a Pradaxa safety review because of reports of fatal bleeding. Weeks after the FDA announced the beginnings of its review, the Institutes for Safe Medicine Practices released reports showing that over 500 cases of Pradaxa-linked bleeding were reported to the FDA during the first quarter of 2011. These hemorrhaging cases led to death, hospitalization and other severe consequences. [fda.gov/Drugs/DrugSafety/ucm282724.htm; ismp.org/quarterwatch/pdfs/2010Q4.pdf]
Parker Waichman LLP is offering free lawsuit consultations to victims of Pradaxa bleeding side effects. If you or a loved one took Pradaxa and experienced a life-threatening bleeding event following a minor trauma, please contact their office by visiting the firm's Pradaxa traumatic bleeding page at http://www.yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
For more information regarding Pradaxa bleeding lawsuits and Parker Waichman LLP, please visit: http://www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Herbert Waichman, Partner