Individuals who experienced internal bleeding injuries while on Pradaxa may be eligible to file a Pradaxa lawsuit.

Pradaxa (dabigatran) is an anticoagulant manufactured by Boehringer Ingelheim Pharmaceuticals. The drug was approved by the U.S. Food and Drug Administration (FDA) in October 2010 and is part of a class of drugs known as direct thrombin inhibitors.

Pradaxa was marketed as a superior option to warfarin because it requires less monitoring and little to no dietary changes. Warfarin has been the industry standard blood thinner for over 60 years. Many new anticoagulants released in the United States compete with warfarin, the standard drug which patients and physicians trust.

However, shortly after the drug’s release patients and physicians began to report bleeding events related to the blood thinner. In the first three months on the market, the FDA received 307 reports of Pradaxa bleeding events. Within the first year, there were allegedly 260 reported deaths due to internal bleeding related to Pradaxa.

In December 2011, the FDA issued a warning notifying consumers and physicians of the serious uncontrollable bleeding risk possibly associated with Pradaxa use.

Reported complications include internal bleeding, kidney bleeding, gastrointestinal bleeding, heart attack, stroke, brain hemorrhage, and death. Symptoms of internal bleeding can vary depending on the location and severity of the bleed. However, common symptoms include frequent nose bleeds, bleeding from the gums, discolored urine, red or black stools, coughing up blood, and vomiting blood.

In October 2015, the FDA approved a Pradaxa antidote called Praxbind. The antidote has proved effective in reversing the effects of Pradaxa, making Pradaxa the only modern blood thinner with an FDA approved antidote.

However, until October 2015, Pradaxa did not have an available antidote and uncontrollable bleeding could not be managed by flushing the body with vitamin K, as is an option with warfarin. Before Praxbind, the drug’s antidote, was approved, internal bleeding had to be managed with dialysis and blood transfusion. Patients who experienced bleeds during this time were not fortunate enough to have an antidote on hand, making the risks of internal bleeding far more dangerous.

Many patients have filed a Pradaxa lawsuit against Boehringer, alleging the manufacturer did not sufficiently warn about the potential bleeding risks associated with the drug. Other patients who have filed a Pradaxa lawsuit alleged that the company knew about the risk but didn’t notify patients or physicians of the risks. Similarly, a Pradaxa lawsuit may argue that the documentation about the side effects and safety of the drug were misleading.

Boehringer settled thousands of Pradaxa lawsuit complaints in 2014, but additional Pradaxa lawsuit cases may be filed for victims who did not participate in the first settlement. The $611 million settlement fund awarded in 2014 compensated plaintiffs for damages while also allowing them to file a Pradaxa lawsuit without having to pay attorneys fees upfront.

If you or a loved one developed an internal bleed after taking Pradaxa, you may be eligible to file a Pradaxa lawsuit. A Pradaxa lawsuit could help recover compensation for medical expenses, lost wages, pain and suffering, mental anguish, loss of consortium, wrongful death, and more. If you qualify, an experienced attorney may be able to assist you in filing a Pradaxa lawsuit.