Pradaxa (Dabigatran) is one of three new generation anticoagulants, or blood thinners, available to patients who are at high risk for stroke or other thrombosis events.

However, a number of patients have alleged serious Pradaxa side effects involving dangerous internal bleeding events. The allegations raised in Pradaxa lawsuits including uncontrollable internal bleeding from the rectum, gastrointestinal tract, and the brain.

After Boehringer Ingelheim had to pay a considerable settlement to settle these charges, the FDA made a public warning regarding Pradaxa side effects in 2011. At the time, the FDA announced that it was evaluating Pradaxa bleeding injury reports.

The agency warned doctors against the potential internal bleeding injuries, and that the events could be potentially fatal. These problems occur from the irreversible treatment mechanism of the blood thinner, which only recently has a bleeding antidote available.

Pradaxa works by inhibiting a certain enzyme thrombin, which is primarily responsible for the body’s ability to clot and stop bleeding. It does this by widening the blood vessels, eliminating the chances of clotting.

However, the anticoagulant not only stops the body from clotting external injuries, it also stops the body from being able to stop internal bleeding injuries. Even though Pradaxa is highly effective in its treatment purpose, its mechanism has resulted in numerous bleeding injuries.

When internal hemorrhage occurs, emergency intervention is often required to save the patient’s life. It was not until October 2015 that Boehringer Ingelheim finally had Praxbind, Pradaxa’s bleeding antidote, was available to patients.

Pradaxa Lawsuit Allegations

Previously Warfarin had been the primary choice for patients until Pradaxa’s approval in 2010, which came with its own bleeding antidote for patients.

Pradaxa had quickly overtook Warfarin in popularity for its convenience, with patients being able to have the drug prescribed in a single dose. According to Pradaxa lawsuits, many patients were convinced to take the drug for its convenient and were not adequately warned against internal bleeding events.

In 2011 the FDA stated that 542 internal bleeding injury reports were fatal, with the Safe Medication Practices reporting that Pradaxa was connected to the highest number of injury reports out of the 800 drugs reviewed. The high number of reported serious Pradaxa side effects had led to the FDA, to release its 2011 warning.

Even though the blood thinner now has its own bleeding antidote, this development came too late to many patients. A number of Pradaxa lawsuits have been filed against Boehringer Ingelheim, for failing to warn patients against potential internal bleeding injuries.

In addition to these claims of negligence, many allege that Boehringer Ingelheim had deliberately concealed this information from the public to protect Pradaxa’s market value. During late May 2014, Boehringer Ingelheim had agreed to pay $650 million to settle 4,000 state and federal Pradaxa lawsuits.

Currently there are over 250 Pradaxa lawsuits that have gone to federal court, with more claims expected to come. Patients who suffered injuries may be eligible to file a Pradaxa lawsuit against Boehringer Ingelheim. An experienced Pradaxa attorney can review your case at no cost and help you decide if filing a Pradaxa lawsuit is right for you.