FDA to Investigate Pradaxa Bleeding Side Effects after Thousands of Complaint Reports are Recorded
Safety outcomes associated with a blood-thinner involved in mounting Pradaxa lawsuit litigation, as well as its predecessor, warfarin, are being evaluated by the FDA as part of the federal agency’s surveillance system, according to recent reports.
An article published January 6th on the website, “Medical Marketing and Media,” indicates that the evaluation, which is part of the FDA’s Mini-Sentinel initiative, will work to “assess systematically the rates of bleeding and thromboembolic outcomes associated with the use of dabigatran and warfarin for patients with atrial fibrillation,” and follows regulators’ claims in November 2012 that the risk for Pradaxa internal bleeding side effects were no higher than warfarin.
But where does that leave the thousands of patients who have filed lawsuits alleging fatal and near-fatal episodes of Pradaxa bleeding?
Over 2,000 Pradaxa Lawsuits Now Filed in Illinois Federal Court
According to a Case List update issued in January 2014 by the U.S. Judicial Panel on Multidistrict Litigation (JPML), a total of 2,086 claims against the blood thinner’s manufacturer, Boehringer-Ingelheim have been filed in Illinois federal court. Specifically, court documents indicate that instances of internal hemorrhaging, as well as cerebral and gastrointestinal bleeding are included in claims now pending in the U.S. District Court, Southern District of Illinois, have been alleged by plaintiffs who go on to say that Pradaxa’s manufacturer failed to provide adequate warning about its risk for complications. These side effects are especially dangerous, according to lawsuits, since there is no readily-available antidote to stop Pradaxa bleeding once it begins. Although warfarin may also cause internal bleeding side effects, they can be reversed with the administration of Vitamin K.
According to an October 2013 update from the Institute for Safe Medicine Practices, Pradaxa logged more complaint reports in 2012 than any other medication tracked by the FDA. That year, the agency recorded more than 3,200 Pradaxa side effect reports, which included 580 deaths.
This information seems to not have had negative ramifications on sales of the drug, however. According to the “Medical Marketing and Media” report, Boehringer reported $811 million in Pradaxa sales for the first half of 2013.
Considering a Pradaxa Lawsuit? Contact Us Today.
If you or a loved one experienced Pradaxa bleeding injuries, you may be eligible to file a claim against Boehringer-Ingelheim. Contact our team of experienced lawyers today for more information: (877) 779-1414.