Pradaxa is one of the most popular anticoagulants on the market, with numerous patients being prescribed this medication. These patients are often suffering from atrial fibrillation and therefore are at a high risk of stroke; Pradaxa and other blood thinners work to decrease the risk of stroke and blood clots.

Unfortunately, Pradaxa has been associated with numerous internal bleeding complications, with some cases resulting in fatal outcomes.

This new-generation anticoagulant was approved by the FDA in 2010, and is manufactured by German pharmaceutical giant, Boehringer Ingelheim Pharmaceuticals. This drug is part of a medication class called direct thrombin inhibitors, which work by inhibiting the enzyme in blood that causes it to clot. Pradaxa was the first drug in decades to be approved for anticoagulant purposes since the release of Warfarin in the 1960s.

When Pradaxa was released, it was advertised to be more convenient than Warfarin, as it was only prescribed in one dose. Traditionally, Warfarin patients had to frequently go to doctor appointments for dose adjustments, whereas Pradaxa patients do not have to undergo frequent monitoring by their physicians.

Unfortunately, Pradaxa and other new-generation anticoagulants, Xarelto and Eliquis, have allegedly caused numerous internal bleeding incidents in patients. Another difference between Warfarin and new-generation anticoagulants is that there is no approved clotting agent in the case of internal bleeding injuries for the newer drugs. This means that in the case of internal bleeding injuries for Pradaxa patients, emergency medical intervention is often needed.

Overview of Pradaxa Bleeding Complications

According to experts, the risk of Pradaxa bleeding may be higher if the patients are taking other medications like aspirin, non-steroidal anti-inflammatory drugs, or other blood thinners. Research suggests that there are also serious concerns regarding gastrointestinal bleeding and Pradaxa use, with findings showing that:

• 16.6% of all users may experience some Pradaxa internal bleeding
• 3.3% of all users may experience serious bleeding on Pradaxa
• 1.5% of all users may experience life-threatening Pradaxa bleeding effects
• 0.3% of all users may experience brain hemorrhage on Pradaxa

According to the Institute for Safe Medication Practices, more than 307 Pradaxa injury reports that were filed with the FDA during the first three months of the drug being on the market. This exceeds 98.7% of other drugs monitored by the organization and is 50% more than were associated with Warfarin.

Despite the risk of internal bleeding, the FDA has not indicated that there will be no recall in the United States, but other countries are closely monitoring these anticoagulant patients. For example, in August 2011, the Japanese health ministry sent a request letter to Boehringer Ingelheim Pharmaceuticals, stating that the drug maker needed to warn doctors about the risk of Pradaxa bleeding complications. This letter was sent after 81 elderly patients in the country suffered internal bleeding injuries, with at least 14 deaths allegedly caused by Pradaxa.

In December 2011, the FDA issued a public warning against potential Pradaxa complications. While the agency indicated that internal bleeding is expected in using anticoagulants, the agency stated that Pradaxa bleeding complications could be unreasonably dangerous to patients.

Despite the risk of Pradaxa bleeding, the pharmaceutical company did not include this possible side effect on the drug’s label. This has led numerous patients to file legal action against Boehringer Ingelheim Pharmaceuticals.

In late May 2014, the drug company announced that it would pay $650 million in settlements to resolve claims in 4,000 state and federal Pradaxa lawsuits.