The blood thinner Pradaxa,  prescribed to prevent blood clots and strokes in patients with atrial fibrillation or who have undergone surgery, is associated with a risk of severe internal bleeding.

The FDA approved Pradaxa in 2010, and within six months, patients were reporting serious bleeding events. Although the federal agency has received over 4,000 reports of Pradaxa side effects and 542 deaths among users, a recall has yet to be issued.

The maker of the drug, Boehringer Ingelheim Pharmaceuticals, also allegedly failed to warn of these potential Pradaxa complications and of the fact that the drug has no antidote to stop the bleeding.

Pradaxa Bleeding Side Effects

Pradaxa was released to great fanfare, with its manufacturer touting it being safer than the traditional blood thinner Warfarin (coumadin). Used primarily by people who suffer from atrial fibrillation, or an irregular heartbeat, the new generation blood thinner is supposed to minimize the risk of suffering from a stroke and other serious problems.

One of the major concerns regarding Pradaxa is that if an internal bleed is discovered, there is no known reversal agent as there is for Warfarin. Since there is no antidote the risk of deadly bleeding is higher.

Many of these reported problems have led to Pradaxa bleeding lawsuits being filed against the drug’s manufacturer. The latest allegations to emerge from documents in these Pradaxa lawsuits show the manufacturer may have concealed evidence of bleeding risks because of the negative impact the findings may have had on the marketing of the medication.

The FDA is continuing to review Pradaxa side effects as well as other anticoagulants to evaluate the effectiveness and safety of the products although the agency had initially maintained that Pradaxa and other blood thinner medications were equal in terms of bleeding risk.

Pradaxa Lawsuits

Due to the number of Pradaxa bleeding claims filed, cases were consolidated to a special federal multidistrict litigation in Illinois under U.S. District Judge David Herndon.

During the course of litigation, evidence was presented that showed that Boehringer Ingelheim Pharmaceuticals knew of the internal bleeding risks of the drug, concealed internal studies rather than warn patients, and even destroyed evidence requested by the court.

In May 2014, at the start of trials over Pradaxa internal bleeding, Boehringer Ingelheim opted to pay approximately $650 million to settle all pending Pradaxa lawsuits. The administration of this settlement was completed this past spring.

In March, a new round of Pradaxa lawsuits began for victims who were closed out of the initial settlement.

If you or someone you love suffered from serious Pradaxa complications such as internal bleeding, you may be eligible to file a Pradaxa lawsuit to recover damages for your pain and suffering.