The lawsuits involving Pradaxa are centered on the allegation that, unlike other blood thinners, the drug doesn’t have a reversal agent in the event of a bleeding emergency, and that this can put patients at risk for disabling or even fatal consequences.
Tampa, FL (PRWEB) December 03, 2012
Approximately one year after announcing that it would be evaluating post-marketing reports of bleeding in Pradaxa users, the FDA has reported that it did not find a higher risk of bleeding in Pradaxa users when compared to those taking warfarin, Morgan and Morgan reports.
While the FDA announced that “bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin,” it failed to point out that the drug, unlike warfarin, lacks an antidote to reverse its anticlotting effects, according to the New York Times*.
“The lawsuits involving Pradaxa are centered on the allegation that, unlike other blood thinners, the drug doesn’t have a reversal agent in the event of a bleeding emergency, and that this can put patients at risk for disabling or even fatal consequences,” said Michael Goetz, head of Morgan and Morgan’s mass tort section. “I have spoken to a number of patients who switched from Coumadin to Pradaxa and suffered severe and life-threatening bleeds.”
Approved in Oct. 2010, Pradaxa was heralded as the first in a new wave of drugs expected to replace the decades-old Coumadin, the New York Times reports. Unlike Coumadin, Pradaxa did not restrict the patient’s diet or require frequent blood testing; however, while the effects of Coumadin could be reversed with vitamin K, no such antidote has been made available for users of Pradaxa, according to the article. Although Boehringer Ingelheim recommends dialysis for bleeding Pradaxa users, several doctors told the New York Times that such an option was not realistic.
More than 100 Pradaxa lawsuits** have been filed, claiming that surgeons, emergency room doctors and other healthcare professionals were not properly warned about the drug’s lack of an antidote and have been left without an effective way to treat uncontrollable bleeding in Pradaxa users. As litigation involving the blood thinner moves forward, the Pradaxa attorneys at Morgan and Morgan continue to offer a free case review to anyone who suffered a severe bleed while taking the drug, as well as loved ones acting on their behalf. For more information, please visit http://www.forthepeople.com/pradaxa-bleeding-lawsuits--11-4104.html today.
About Morgan & Morgan
Morgan & Morgan is one of the largest exclusively plaintiffs’ law firms in the country with 15 offices throughout Florida, Georgia, Mississippi, Tennessee, and New York. The firm handles cases nationally involving personal injury, medical malpractice, consumer class action, and securities fraud, as well as complex litigation against drug and medical device manufacturers. Visit Morgan & Morgan online at http://www.forthepeople.com/ for a free case evaluation and information about your legal rights.
*New York Times, “A Promising Drug with a Flaw,” Nov. 2, 2012
** MDL No. 2385, IN RE: Pradaxa Product Liability Litigation, Southern District of Illinois
fda.gov/Drugs/DrugSafety/ucm326580.htm