Pradaxa Bleeding Events Continue to Pile Up with No Antidote in Sight

According to consumer reports, bleeding events exacerbated by the anticoagulant Pradaxa are continuing to lead to untimely deaths. The Houston Press reports that the manufacturer Boehringer Ingelheim received reports of 260 Pradaxa-related fatal bleeding events worldwide between March 2009 and October 2011. Consumer complaints and heartbreaking stories have confirmed that this number has only risen further, leading some to call for the removal of the popular blood thinner from the market and others to question the legal culpability of its manufacturer. In fact, the Houston Press recently reported a story of a Pradaxa user who fell on her kitchen floor and suffered an intracranial hemorrhage which was unable to be stopped by her doctors. The news source reported that the woman’s daughters claimed that all the doctors could do was to make their mother “as comfortable as possible as her speech became slurred and the blood pooled in her skull.”

This lack of an antidote poses a considerable risk for many patients, especially the fall-prone elderly.

Pradaxa (dabigatran) is an oral blood thinner in class of drugs called direct thrombin inhibitors, prescribed to prevent strokes among patients with non-valvular atrial fibrillation (a kind of irregular heartbeat). Pradaxa’s predecessor, Coumadin (Warfarin), was introduced in 1948 and has been the only reliable anticoagulant since. Warfarin reacts negatively with many other drugs and vitamins, so it is a relative pain to prescribe and monitor. Therefore, Pradaxa has been seen by many as a replacement for Warfarin, and its popularity has exploded in popularity since its approval by the FDA in September, 2010.

Doctors and researchers believe that the problem with Pradaxa, though, is that it is impossible to stop bleeding complications in patients because there is no known effective reversal agent to counteract the blood-thinner. Therefore, when someone falls and experiences internal bleeding, it may not be able to be stopped. Currently, the only reversal option for Pradaxa is emergency dialysis, but this can only be done in a very limited timeframe. This lack of an antidote poses a considerable risk for many patients, especially the fall-prone elderly. Bleeding events for people on Warfarin can be reversed by administering vitamin K, fresh frozen plasma, or PCCs (prothrombin complex concentrates).

Pradaxa is manufactured by Boehringer Ingelheim Pharmaceuticals Inc., which is a family-owned company based in Germany. In December, the FDA agreed to review mounting post-market reports of bleeding complications, but have yet to release any new warnings on the drug. However, the FDA said that it "continues to believe that Pradaxa provides an important health benefit when used as directed.” Several lawsuits have been filed against the pharmaceutical company Boehringer Ingelheim for their failure to warn doctors and patients of the considerable risks posed by Pradaxa. If you or a loved one has experienced a bleeding event or death while using or after use of the blood thinner Pradaxa (dabigatran), fill out our free case review form and see if you might be eligible to file a lawsuit to seek compensation for your injuries.