When the FDA approved Pradaxa in 2010, making it the first blood thinner to be approved since Warfarin was approved in the 1950s.

At the time of its release, Pradaxa was advertised to be more efficient and faster acting, cause fewer bleeding complications, and easier to manage than Warfarin.

According to the Nature Reviews Drug Recovery, medical experts stated that they were excited about the release of Pradaxa because it gave physicians the opportunity to try different treatment options for atrial fibrillation patients.

Medical experts also pointed out several clinical trials, which showed that Pradaxa could be prescribed in one dose but showed a tendency for internal bleeding injuries.

Despite the fact that Pradaxa had reportedly shown a tendency to cause internal bleeding complications, Pradaxa’s maker Boehinger Ingelheim did not widely describe them on the drug’s label.

Instead, the company focused on advertising the status of the first anticoagulant to be approved since Warfarin, told patients that Pradaxa could be prescribed in a single dose, and was supposedly faster-acting than Warfarin.

Pradaxa has proven to be just as effective as Warfarin in preventing stroke and blood-clot formation. And Pradaxa’s released was followed up by the release of the blood thinners Xarelto and Elquuis.

Along with Pradaxa, they are advertised to be faster-acting and more convenient than Warfain. However, they were also reportedly linked to internal bleeding.

Overview of Pradaxa Complications

Internal bleeding is a risk attached to any anticoagulant, but it is the leading cause of death for Pradaxa users. According to medical experts, Pradaxa and other new-generation anticoagulants lack the vital safety features of Warfarin, which makes them more dangerous than the original anticoagulant.

Unlike Warfarin, Pradaxa does not come with a reversal agent in the case of internal bleeding, creating the need for emergency medical intervention.

Furthermore, Warfarin patients were required to frequently see their physicians to adjust their dose amount, to prevent bleeding incidents.

The new-generation anticoagulants do not have this requirement. Experts believe that if Pradaxa patients were given the same instructions, then many internal bleeding events could have been avoided.

According to the FDA, Pradaxa has been alleged to cause thousands of bleeding reports, with 541 of them being fatal. In 2011, the Institute of Safe Medication Practices reported that Pradaxa was linked to more deaths than any other drug prescribed in the United States.

At the time around this report came out, there had been numerous Pradaxa lawsuits filed against Boehringer Ingelheim, alleging product liability and negligence charges.

The customers claimed that the company had failed to warn them against Pradaxa bleeding complications, and they were unaware of the risk they were placing themselves in.

By late May 2014, Boehringer Ingelheim had to pay $650 million to settle 4,000 Pradaxa lawsuits.