Pradaxa was the first drug to break into the exclusive anticoagulant market since the release of Warfarin, dominating the sales soon after its release. Today Pradaxa’s manufacturer, Boehringer Ingelheim Pharmaceuticals, faces thousands of Pradaxa lawsuits and has settled hundreds of millions of dollars in damages attributed to Pradaxa side effects.

For over 50 years, Warfarin was the only blood-thinner available in the United States to treat major blood clot conditions. The pharmaceutical world was forever changed in the month of October 2010, as Pradaxa was approved and was the first official competition Warfarin had in the United States. It soon overtook Warfarin’s place in the market, because it not only could be prescribed to treat similar conditions, like atrial fibrillation, but had also required less maintenance from the patients, as well as less side effects. However, the new generation anticoagulant was soon dethroned when reports of dangerous and sometimes irreversible Pradaxa bleeding events started to pour in.

After the first year on the market, 16 percent of all atrial fibrillation patients were taking Pradaxa, compared to the 44 percent who were taking Warfarin. While the first anticoagulant was still more popular during that time, the notoriety Pradaxa gained was astounding to marketing experts. By August 2012, over 3 million patients in the United States had been prescribed Pradaxa, with first quarter annual sales reaching $209 million. Marketing experts speculate that Pradaxa’s success stemmed from Boehringer Ingelheim’s aggressive marketing campaign, which consisted of spending $464 million in promoting the drug.

It is important to note that the anticoagulant market is estimated to bring in about $10 billion a year in the United States alone, causing many drug companies to salivate at the sight of an opening. Pradaxa proved this to be true, as another anticoagulant was approved a year later in 2011, Xarelto, which was released as a joint effort between Janssen Pharmaceuticals and Bayer Pharmaceuticals. Eliquis was recently released in 2012, also as a joint effort between two other drug giants, Pfizer and Bristol Meyers.

However, the release of the new blood thinner also spawned a stream of Pradaxa complications that were also found in Xarelto and Eliquis. Just two years after its release, more than 500 deaths were reportedly caused by Pradaxa bleeding complications. In May 2014, Boehringer Ingelheim settled over 4,000 Pradaxa internal bleeding lawsuits, agreeing to pay $650 million to settle all multidistrict litigations centering around the drug’s bleeding complications. However, Boehringer Ingelheim has admitted to no wrongdoing, and has pointed out that Pradaxa benefits outweigh Pradaxa bleeding risks.

Overview of Pradaxa Bleeding Complications

Pradaxa bleeding incidents have been rampant since its release in 2010, but it was not until 2011 litigation action turned serious. As mentioned before, Pradaxa was approved to treat atrial fibrillation and certain other blood clotting conditions like venous thromboembolism. While Warfarin also treats these conditions, the original anticoagulant also comes with a significant benefit that the new-generation blood-thinners lack, a Pradaxa antidote or reversal agent. In contrast to Pradaxa and the other new anticoagulants, Warfarin comes with a stopping agent in the case of internal bleeding.

While Pradaxa and the other blood-thinners have proven to work, in some cases they work too well. Many patients have reported that once internal bleeding occurs, it can be very difficult to stop and may require emergency intervention. For Warfarin, this was not as much of an issue because if the patient applied vitamin K, then the bleeding events would typically be resolved. Pradaxa and the other new anticoagulants do not have this feature, and require hospital intervention in these cases.

Additionally, Warfarin patients must undergo regular doctor visits, blood tests, and diet restrictions. With such maintenance, medical experts believe it was these requirements that prevented so many Warfarin bleeding deaths. Unfortunately Pradaxa does not have these maintenance requirements, making the blood thinner very popular but at the same time dangerous for patients.