Drug manufacturer Boehringer Ingelheim Pharmaceuticals is under scrutiny, as Pradaxa consumers claim the company failed to warn of the serious internal bleeding side effect risks that have reportedly led to more than 500 deaths. The U.S. Food and Drug Administration has also received thousands of consumer reports of severe bleeding events in just a few short years of Pradaxa’s introduction to the pharmaceutical market.

Many patients who have filed Pradaxa lawsuits allege that the drug makers not only failed to adequately warn of the life-threatening bleeding risks, but they also did not inform consumers that should a bleeding event occur, there is no known antidote to stop it.

Pradaxa Overview

Pradaxa is one of the new generation of blood thinners that was FDA approved in 2010 to reduce the risk of stroke in atrial fibrillation patients. Since its initial release, Pradaxa has also been approved to treat blood clots in the legs and lungs. The approval for Pradaxa was “fast tracked,” meaning there was only one clinical trial used before its release on the market.

The blood thinner was marketed as a more convenient option when compared to Warfarin (Coumadin) because it does not require monthly blood tests or carry any dietary restrictions. However, within the first few months of its release, the FDA received more than 300 severe adverse event reports claiming the new anticoagulant caused serious Pradaxa internal bleeding and other health complications.

Pradaxa Bleeding Risks

Pradaxa has been popularly marketed as a more convenient blood thinner when compared to Warfarin; however, when it comes to internal bleeding risks, consumers claim they were unaware that there was no way to stop Pradaxa bleeding.

If a Warfarin (Coumadin) consumer experiences excessive bleeding, patients can be given a dose of vitamin K to stop the bleeding event. However, Pradaxa patients who suffer from internal bleeding will have to undergo blood transfusions until the medication is out of their system, since there is no antidote or reversal agent. 

Blood Thinner Study

A recent study performed by researchers trying to compare Warfarin bleeding risks to Pradaxa bleeding risks found that the new-generation of blood thinners may not be as safe as consumers are led to believe.

In a study performed by Johns Hopkins Bloomberg School of Public Health and George Washington University, researchers analyzed more than 46,000 patients who were prescribed either Pradaxa, Xarelto or the more traditional blood thinner Warfarin. The study found that the newest blood thinners carry a higher risk of internal bleeding when compared to Warfarin, a medication that has been around for more than 50 years.

Pradaxa Lawsuits Continue to Grow

More than nine million Pradaxa prescriptions have been filled in the United States since its release on the market in 2010. Consumers who believe Pradaxa’s manufacturer Boehringer Ingelheim Pharmaceuticals was negligent in their warnings of Pradaxa bleeding risks have filed Pradaxa lawsuits in state and federal courts.

Thousands of Pradaxa lawsuits have been filed so far and the number continues to grow across the nation. More than 4,000 Pradaxa lawsuits have resulted in settlements. Contact a Pradaxa lawyer to find out if you can join a Pradaxa class action lawsuit.