The blood thinner Pradaxa is prescribed to prevent blood clots and stroke in patients with atrial fibrillation or who have undergone surgery.

Unfortunately, repeated warnings have now associated the blood thinner with severe internal and uncontrollable Pradaxa bleeding risks.

Pradaxa Bleeding Risks and Complications

Pradaxa (dabigatran) was the first of a new class of blood thinners called novel oral anticoagulants to be introduced in the United States in 2010, and was followed by others including Xarelto and Eliquis.

These drugs were aggressively marketed as superior and more convenient alternatives to warfarin (Coumadin), the leading blood thinner for decades.

Initially, Pradaxa and related drugs appealed to patients who did not want to subject themselves to routine blood monitoring necessary to ensure proper blood clotting in patients taking warfarin.

Additionally, dietary restrictions required for warfarin users also seemed to make Pradaxa a more convenient alternative.

However, many patients now claim that they were not made aware of Pradaxa bleeding risks.

Since the blood thinning drug Pradaxa came to market, drug maker Boehringer Ingelheim has faced a growing number of lawsuits based on claims that patients were not warned of serious Pradaxa bleeding risks associated with the drug, nor of the lack of an antidote for Pradaxa internal bleeding until recently.

Antidote for Pradaxa Bleeding Released

Last October, the FDA gave accelerated approval to Praxbind (idarucizumab) for emergency situations when the drug is needed to reverse the effects of Pradaxa internal bleeding episodes.

Praxbind’s safety and efficacy was studied in three trials with 238 healthy volunteers who were given Pradaxa and 123 patients on Pradaxa who actually needed the drug.

When Praxbind was administered to the healthy volunteers, researchers found an immediate drop in the amount of Pradaxa in their blood. This reduction lasted for at least 24 hours. The most common side effect was headache.

The 123 Pradaxa patients who got Praxbind needed it as they were having either uncontrolled bleeds or emergency surgery. This trial is ongoing and has thus far shown appreciable success. The time to full Pradaxa reversal in 89 percent of patients was within four hours.

Pradaxa Victims Have Legal Options

Even with the fast-tracked approval and release of Praxbind, the antidote has come too late for many patients and grieving families who died from Pradaxa internal bleeding events. Many of these surviving family members or patients have filed lawsuits against Boehringer Ingelheim.

Patients who suffer injuries after taking Pradaxa have legal options. When a pharmaceutical drug like Pradaxa is responsible for patient injuries, patients can sue the drug manufacturer.

These product liability lawsuits seek to hold manufacturers accountable for their dangerous and defective products.

Patients who successfully sue can recover compensation from the manufacturer. This can cover the cost of medical bills, lost wages from time off work, and the pain and suffering experienced by patients with serious medical issues.

In fact, thousands of patients have already filed Pradaxa lawsuits. These lawsuits contend that Boehringer Ingelheim failed to warn doctors and patients about Pradaxa bleeding risks. They also contend that the company defectively designed Pradaxa in a manner that made the drug unsafe for patients.

In May 2014, Boehringer Ingelheim Pharmaceuticals agreed to settle around 4,000 claims regarding Pradaxa for approximately $650 million. The Pradaxa settlement covers claims in both state and federal courts. In agreeing to the settlement, Boehringer Ingelheim did not admit to any liability.

Although Boehringer Ingelheim Pharmaceuticals agreed to settle thousands of Pradaxa lawsuits, the drug maker is still facing thousands more claims in federal court, alleging that users suffered severe and often fatal bleeding problems after using the controversial blood thinner.

If you or someone you love has suffered serious injury or even death due to Pradaxa internal bleeding, you could be entitled to compensation for your damages. To learn more, please contact a personal injury lawyer for a free consultation.