New research continues to surface that the anticoagulant Pradaxa carries a serious internal bleeding risk and there is no antidote to stop it.

More than 9 million Americans have been prescribed Pradaxa since its introduction on the market a few years ago but the blood thinner has already been named to be the cause of more than 1,000 near fatal bleeding events. Many consumers claim they were not adequately warned that the medication carried a risk for internal bleeding or that should it occur there would be no easy way to get the Pradaxa bleeding under control.

Pradaxa Study

In a recent study performed by Johns Hopkins Bloomberg School of Public Health and George Washington University, researchers studied more than 46,000 patients that were prescribed either Pradaxa, Xarelto or the more traditional blood thinner Warfarin. The study compared the internal bleeding risks of the new anticoagulants to Warfarin which has been prescribed for decades. Researchers found that the latest blood thinners including Pradaxa carry a high risk of internal bleeding especially when compared to Warfarin.

Researchers determined that the risk of internal bleeding caused by the new-generation of blood thinners may outweigh the potential benefits.

What is Pradaxa?

Pradaxa was approved by the FDA in 2010 to reduce the risk of stroke in patients who have been diagnosed with atrial fibrillation, which is a heart condition that effects millions of Americans. Physicians treating atrial fibrillation patients will often determine if a blood thinner is needed to treat the medical condition. They then factor in other elements such as if the patient has high blood pressure, a history of strokes, or diabetes in order to decide which anticoagulant will be the most effective in treating their condition. Pradaxa is often prescribed to atrial fibrillation patients. The medication has also been approved to treat blood clots in the legs and lungs.

Pradaxa marketers claim the medication is more convenient than Warfarin (Coumadin) because there’s no dietary restrictions and no regular blood testing required to take it. However, thousands of Pradaxa consumers claim the drug caused life-threatening internal bleeding which was a side effect risk they were not aware of.

Pradaxa Complications

Within the first few months of being on the market, more than 300 severe adverse event (SAE) reports were filed with the FDA claiming Pradaxa caused internal bleeding and other health problems. Since that time, Pradaxa has been named as the cause of death in more than 500 patients. While bleeding risks may occur with any blood thinners, the risk with the new generation of anticoagulants may be more severe since there’s no way to stop it.

If excessive bleeding occurs in patients taking Warfarin, they can be given a dose of vitamin K to get it under control. However, with Pradaxa patients there is no known antidote so patients who experience Pradaxa internal bleeding have to suffer through multiple blood transfusions as the only way to stop the bleeding is to get the medication out of their system. 

Pradaxa Lawsuits

Thousands of lawsuits have been filed against Pradaxa’s manufacturer Boehringer Ingelheim Pharmaceuticals alleging that the company downplayed the risks of internal bleeding and did not inform consumers there was no antidote if that should occur. More than 4,000 Pradaxa lawsuits have been settled so far, for a total of $650 million.

Contact a Pradaxa attorney to find out if you can join a Pradaxa class action lawsuit.