One of the newest blood thinners on the U.S. market has only become more popular since its release in 2010, as more than 9 million Pradaxa prescriptions have been filed so far.

However, recent studies have suggested that the anticoagulant medication carries a significantly higher risk of internal bleeding complications when compared to the more traditional blood thinner Warfarin (Coumadin).

In a study performed by Johns Hopkins Bloomberg School of Public Health and George Washington University, researchers set out to compare the bleeding risks between Warfarin and the new line of blood thinners. The study followed more than 46,000 patients taking either Pradaxa, Xarelto, or Warfarin and found that consumers taking Pradaxa or Xarelto had a higher risk of internal bleeding side effects when compared to Warfarin.

Researchers indicated that the increased Pradaxa internal bleeding risks outweighed any potential benefits of taking the medication.

Pradaxa Internal Bleeding Complications

Pradaxa was manufactured by Boehringer Ingelheim Pharmaceuticals to be used as a way to reduce the risk of stroke in atrial fibrillation patients. It has since also been approved to be used as a blood clot treatment.

However, in the last few years, the U.S. Food and Drug Administration (FDA) has received thousands of adverse reports from consumers who allege they have suffered from serious Pradaxa internal bleeding complications. Hundreds of these reports claim Pradaxa use led to a hemorrhage related death.

Pradaxa Bleeding Risks

Pradaxa was the first blood thinner medication approved since Coumadin (warfarin), which dominated the market for more than 50 years. The approval process for Pradaxa was “fast tracked,” meaning there was only one clinical trial conducted before its release on the market.

It was originally promoted by Boehringer Ingelheim Pharmaceuticals as a more convenient blood thinner when compared to Warfarin, as manufacturers claimed patients would no longer have to endure regular blood testing or have any dietary restrictions.

However, Pradaxa consumers who have experienced severe internal bleeding claim they were unaware that there is no known Pradaxa internal bleeding antidote should an event occur.

Coumadin patients who experience excessive bleeding can be given a dose of vitamin K to get it under control. However, users who experience Pradaxa internal bleeding must go through multiple blood transfusions, as it is the only way to stop Pradaxa internal bleeding is to get the medication out of the system.

Experts have indicated that Pradaxa manufacturers may have erred by suggesting that the blood thinner did not require blood monitoring. They claim that regular blood testing may have helped doctors determine who is at an increased Pradaxa internal bleeding risk.

Pradaxa Lawsuits

Thousands of Pradaxa internal bleeding lawsuits have been filed accusing Boehringer Ingelheim Pharmaceuticals of intentionally hiding the risk of bleeding complications from consumers and failing to disclose the lack of a Pradaxa antidote. Pradaxa’s manufacturer has acknowledged that a Pradaxa bleeding reversal agent is needed and claims that they are in the process of getting an antidote approved.

Medical experts report Pradaxa internal bleeding has caused more than 500 fatalities and more than 1,000 near deaths due to uncontrollable bleeding complications. To date, more than 4,000 Pradaxa lawsuits have been settled for a total of $650 million.

Contact a Pradaxa attorney to find out if you should file a Pradaxa lawsuit as an individual or join a Pradaxa class action lawsuit.