Bleeding Deaths Linked to Pradaxa [Video]
Watch this news video if you or anyone you know is on a blood thinner. It could provide life saving information.
Pradaxa, an anticoagulant medication, helps prevent blood clots and strokes. It’s often used with people who have irregular heartbeats. But more than 500 people from around the country have reported to the F.D.A. bleeding deaths involving Pradaxa.
Mikal Watts is the lead counsel in the multi-district litigation of 300 plaintiffs suing the drug maker, a German manufacturer, Boehringer Ingelheim. In a video interview with Lawyers.com Editorial Director Betsy Kim, Mikal says Pradaxa is responsible for thousands of unsuspecting patients suffering from injuries and patients dying. He says the main problem is that Pradaxa has no reversal agent, meaning once it thins the blood, there is no way to stop the bleeding.
In 2010, the F.D.A. approved Pradaxa as an alternative to warfarin (which goes by the brand names Coumadin and Jantoven). Boehringer Ingelheim claims Pradaxa requires less monitoring. However, Mikal says unlike with Pradaxa, if you have a bleeding event while on warfarin, vitamin K can stop the bleeding. He suggests patients on or starting anti-clotting medications should ask if the drug has an antidote.
A Boehringer Ingelheim public relations spokeswoman responded to Lawyers.com with an email stating: “Boehringer Ingelheim believes that the product liability lawsuits filed against the company regarding Pradaxa are without merit and we will vigorously defend each and every case. Boehringer Ingelheim has consistently communicated the benefits and risks of Pradaxa, which are clearly stated in the U.S prescribing information and medication guide that is distributed with every prescription.”
An FDA report dated Nov. 2, 2012 states the drug did not show a higher risk of bleeding than with patients on warfarin. However, the report does not address the medication’s lack of a reversal agent.
Mikal challenges the validity of the studies cited by Pradaxa’s maker and the FDA as biased and uncontrolled. The litigation is moving forward with the first representative case scheduled for August 2014.