As many patients are now aware, the popular anticoagulant Pradaxa can cause devastating internal bleeding injuries. According to several studies, patients using Pradaxa are at least twice as likely to suffer internal bleeding events when compared to patients using an older anticoagulant, Warfarin. This discrepancy is mainly attributed to the fact that there is currently no antidote available to reverse Pradaxa internal bleeding events.

In one of the most recent Pradaxa studies, experts found that the new-generation anticoagulant was twice as likely to cause internal bleeding events comparatively to Warfarin. Published in the October 2013 issue of Circulation, researchers analyzed over 134,000 Medicare patients who were either prescribed Warfarin or Pradaxa to treat their atrial fibrillation. While Pradaxa showed a higher risk for gastrointestinal bleeding and brain hemorrhaging, it had a lower risk of ischemic stroke when compared to Warfarin.

Other studies have found similar results, including a study published in the medical journal JAMA Internal Medicine that also compared Pradaxa and Warfarin side effects in patients. The JAMA study examined more than 1,300 Medicare Pradaxa patients and over 8,000 Warfarin Medicare patients in order to better evaluate the risks of these medications. Once again, the Pradaxa patients showed a higher risk of gastrointestinal bleeding, while brain hemorrhaging was more likely with Warfarin.

Overview of Anticoagulant Bleeding Concerns

For years, Warfarin was the only blood thinner available for patients suffering from atrial fibrillation and other blood-clotting conditions. Warfarin was especially helpful to patients who were at a high risk for stroke. This older drug carried a high risk for internal bleeding events; however, unlike its younger counterparts, Vitamin K was proven to be an effective stopping method. Additionally, patients who were on Warfarin were required to frequently visit their physicians for dose adjustments.

While Pradaxa and the other new-generation anticoagulants do not require extensive medical supervision and were advertised as more convenient and faster-acting than Warfarin, numerous Pradaxa patients have suffered from uncontrollable bleeding events. Many of these Pradaxa patients required emergency intervention to stop the internal bleeding event. Many patients and prescribing physicians complain that the pharmaceutical manufacturers provided little to no warning regarding the possibility of internal bleeding events.

The FDA approved Pradaxa, manufactured by German pharmaceutical company Boehringer Ingelheim, in 2010. Upon its release, Pradaxa quickly overtook Warfarin in popularity and opened the doors for other American drug companies to manufacture and market new-generation anticoagulants. Only a year after Pradaxa’s release, Bayer Pharmaceuticals and the Johnson & Johnson’s subsidiary Janssen Pharmaceuticals collaborated in their own effort to break into the anticoagulant market with Xarelto. After the FDA approved Xarelto in 2011, Pfizer and Bristol-Myers joined the market in 2012 with another new anticoagulant, Eliquis.

According to the FDA, Pradaxa and other new-generation anticoagulants are no better than Warfarin at preventing strokes. This directly contradicts Pradaxa’s advertisements and warning labels, which boast faster-acting and more efficient treatments. Until recently, Pradaxa advertisements made no mention of internal bleeding events or the lack of a stopping agent. These omissions have led to numerous product liability suits against Boehringer Ingelheim, as well as the other new-generation anticoagulant manufacturers.