Product News and Recalls

FDA Fast Tracks Boehringer’s Pradaxa Antidote

pradaxa bleeding antidote being fast tracked by FDAThe U.S. Food and Drug Administration (FDA) has given Boehringer Ingelheim’s antidote to its problematic anticoagulant drug Pradaxa a fast-track review, FiercePhrama reports. According to the company, this will make Pradaxa the first “next generation” anticoagulant to receive an FDA-approved antidote.

Last year, the German drug manufacturer Boehringer Ingelheim agreed to pay $650 million to settle roughly 4,000 Pradaxa lawsuits in state and federal courts. Plaintiffs in Pradaxa lawsuits alleged that Boehringer did not properly warn doctors and patients of the fatal bleeding its anticoagulant could potentially cause. According to FiercePharma, the lawsuits and reports of serious bleeding have taken their toll on Boehringer’s wonder drug.

Other controversial blood-thinning medications, like Bayer’s Xarelto, have yet to receive an FDA-approved antidote. Xarelto, which was approved by the FDA in 2011, is intended to prevent blood clotting in patients undergoing certain surgeries or with irregular heartbeats. Unfortunately, Xarelto has been reported on numerous occasions to have caused severe or fatal bleeding. Patients in Xarelto lawsuits claim that the drug was not adequately tested before its release, and that side effects caused by the medication have been concealed or downplayed by its manufacturers.

Earlier this year, over 100 Xarelto lawsuits were consolidated in a multidistrict litigation, despite fierce opposition from Bayer and Johnson & Johnson. Xarelto lawsuits continue to be filed, swelling the number of cases included in the multidistrict litigation.

Be sure to consult your doctor or physician whenever making changes to your medications. If you or a loved one experienced serious bleeding after using Xarelto or Pradaxa, contact the pharmaceutical lawyers at Lopez McHugh for a free legal consultation. You may be eligible to pursue compensation through your own Xarelto or Pradaxa lawsuit.