The U.S. Food and Drug Administration approved the anticoagulant Pradaxa (dabigatran) to help prevent blood clots and stroke in people with atrial fibrillation, on October 19, 2010. Two years later, the drug had been blamed for more than 500 deaths. In May, 2014, the Pradaxa’s maker settled more than 4,000 lawsuits for injuries and deaths caused by the drug, agreeing to pay $650 million dollars. An antidote that can stop Pradaxa bleeding events was not approved until October 16, 2015, nearly five years after the medication hit the market.
When Pradaxa was introduced, patients and doctors embraced the new drug as a more convenient alternative to warfarin. With Pradaxa there was no routine monitoring required and no dietary restrictions. Doctors liked the ease of prescribing and dealing with fewer compliance issues. Patients liked the fact that they didn’t have to go in for frequent blood tests and that they could eat what they wanted.
Pradaxa was also supposed to carry a lower risk of bleeding events. But, there is a catch. When patients experience a bleeding event, whether caused by the drug or an injury, warfarin’s anticlotting action can be reversed with Vitamin K. When bleeding occurs with Pradaxa, doctors have been helpless to stop it, resorting to extreme and time consuming efforts that often did not work fast enough to save patients from bleeding to death.
Praxbind (idarucizumab) was approved in 2015 under the FDA’s accelerated approval program. That means that little testing was required prior to getting the drug to market, in an effort to make it available as quickly as possible. Hopefully, Praxbind will save lives, but it is little comfort to those who have already suffered serious injury or lost a loved one to Pradaxa bleeding.
If you have been harmed by Pradaxa or another defective drug, please talk to an experienced defective drug attorney right away to learn more about your rights.