Pradaxa internal bleeding events have become well known in the medical community, which has reportedly spurred a mixed reaction. While the overall opinion is to be cautious of any potential Pradaxa side effects, doctors are becoming increasingly wary of prescribing the drug at all.

Pradaxa is a popular new-generation anticoagulant medication, primarily prescribed to treat atrial fibrillation and to ultimately prevent stroke in high-risk patients. While popular at its initial release in 2010, Boehringer Ingelheim has faced major legal backlash from numerous patients who allege they suffered Pradaxa bleeding injuries. In May 2014, Boehringer Ingelheim settled over 4,000 Pradaxa lawsuit for $650 million; each of these claims came from patients who suffered from unexpected Pradaxa bleeding events.

With such happenings, it is not entirely a surprise that many doctors find themselves reluctant to prescribe a drug that may lead to a potentially fatal bleeding injury for patients. That was the opinion of many medical professionals involved in a recent study, which showed that Pradaxa carried a higher risk of gastrointestinal bleeding compared to the traditional blood-thinner known as Warfarin.

Interestingly enough, Pradaxa carried a lesser risk of internal bleeding in the brain compared to Warfarin. Commenting medical experts state that the contrast clearly shows that every blood-thinner carries a significant risk, so it is best to evaluate the benefits and risks of any drug before it is prescribed. Other doctors who reviewed the study stated that alternative remedies should be researched in order to give patients a completely different choice from anticoagulants.

Overview of the Pradaxa Study

The results of this study were published in the online version of JAMA Internal Medicine, on Nov. 3, 2014. This study was led by Inmaculada Hernandez of the University of Pittsburgh, which observed more than 9,400 Medicare patients that were diagnosed with atrial fibrillation in 2010 and 2011; 1,300 of them were prescribed Pradaxa and more than 8,100 received Warfarin. The patients were followed until either their prescriptions ended, they switched to a different blood-thinner, or died at some point before December 2011. The researchers explained that the ultimate goal of this study was to observe the safety profile of both Pradaxa and Warfarin and to better evaluate the risks of Pradaxa side effects. Furthermore, the researchers are proud to state that their study is the first to compare the safety profiles of these medications using a strong national representative sample of Medicare patients.

The results of the study showed rates of internal bleeding events that were more prevalent in Pradaxa users than Warfarin (9 percent compared to 6 percent, respectively). The research team also found that Pradaxa patients were also more likely to suffer from gastrointestinal bleeding, but that Warfarin users carried a higher risk for intracrainal bleeding. Doctors who have reviewed this study are at a loss, because while it is true that Warfarin is arguably safer than Pradaxa and the other new-generation anticoagulants by having a bleeding remedy, it also carries a terrible risk of brain bleeding, which is significantly more dangerous than gastrointestinal bleeding.

It is important to note that Warfarin is the only anticoagulant that requires patients to undergo frequent dose adjustment, and has an easy stopping agent in the case of internal bleeding. While Pradaxa and the newer anticoagulants boast that they can be prescribed in one dose, there is no stopping agent currently available on the market.

Experts noted that the results seemed to conflict with a previous Pradaxa study conducted by the FDA. Additionally, the findings indicate that the risk of Pradaxa was much higher than indicated during the time of its approval by the FDA in 2010. However, critics of the study stated that the inquiry failed to address the specific characteristics between the patients, which may have made some more susceptible to bleeding injuries than others. Overall, experts agree that greater caution should be taken when prescribing any anticoagulant, especially with potentially fatal bleeding events.