Pradaxa (dabigatran) was approved in 2010, and by February 2014, the drug had been linked to over 1,000 deaths and thousands of others harmed by adverse events. Pradaxa is in a class of drugs referred to as “novel oral anticoagulants” (NOACs). It was the first NOAC to receive approval from the U.S. Food and Drug Administration (FDA). NOACs are prescribed as alternatives to warfarin. Pradaxa can cause serious bleeding events, which can be fatal, and has been linked to other serious side effects. If you or someone you love has been harmed by Pradaxa the defective drug attorneys of Ray Hodge & Associates, LLC, can help.
Pradaxa is an anti-clotting drug. It is approved by the FDA for the following uses:
• Reduce the risk of blood clot formation and stroke in people with nonvalvular atrial fibrillation (AFib)
• Treat deep vein thrombosis (DVT) and pulmonary embolism (PE)
• Reduce risk of recurrence of (DVT) and (PE)
• Prevent DVT and PE following hip replacement surgery
Pradaxa was a very exciting drug, when it was new. Before Pradaxa, we had warfarin which requires routine blood monitoring and carries dietary restrictions. For patients, that means inconvenience. For doctors, it means trying to wrangle patients into compliance. Pradaxa was the first alternative and it promised no routine blood monitoring, and no dietary restrictions.
But, the lack of dietary restrictions is a double-edged sword. Vitamin K is the reversal agent for warfarin. People taking warfarin can only eat small amounts of food containing vitamin K or it will interfere with the drug’s efficacy. If you experience a bleeding event on warfarin, vitamin K is administered so your blood can resume clotting. Vitamin K does not reverse the action of Pradaxa, so you can eat whatever you want. The problem is, until October 2015, there was no reversal agent for Pradaxa. Doctors had no way to quickly stop the anti-clotting action in patients who were having bleeding events.
Serious side effects of Pradaxa can include:
• Spontaneous internal bleeding
• Spontaneous gastrointestinal bleeding
• Hemorrhagic stroke
• Uncontrollable bleeding from trauma
• Heart attack or acute coronary syndrome
• Liver failure
• Spinal or epidural blood clots
If you have been harmed by Pradaxa, or lost someone you love to Pradaxa bleeding, you may be able to recover substantial compensation for your losses. In May 2014, Boehringer Ingelheim agreed to pay $650 million to settle over 4,000 Pradaxa lawsuits, rather than have them go to trial. But the harm did not stop with those plaintiffs. There was no antidote for Pradaxa bleeding until Praxbind (idarucizumab) was approved in late 2015.
If you have been harmed by Pradaxa and need an attorney, please call Ray Hodge & Associates, LLC, at (316)269-1414 or contact us online right away to learn more about how we can help you.
Ray Hodge & Associates proudly represents victims and their families across the state of Kansas, including Wichita, Andover, Derby, Goddard, Haysville, Mulvane, Rose Hill, Newton, El Dorado and Hutchinson. Call today for a free consultation all over the state of Kansas. We have proudly served clients in Sedgwick, Butler, Sumner, Harvey, Kingman and Reno Counties.