In 2010, Pradaxa became the first new anticoagulant introduced on the U.S. market in more than 50 years. Pradaxa was marketed as just as effective as Warfarin (Coumadin) in preventing blood clots.

The new blood thinner also claimed to be easier to use as it has no dietary restrictions and does not require regular blood testings.

However, physicians claim that it didn’t take long before noticing that Pradaxa caused more internal bleeding events than they had expected. Since its introduction, Pradaxa has been named in thousands of near fatal bleeding episodes and hundreds of deaths.

New research confirms that Pradaxa carries a higher risk of internal bleeding and consumers claim they were not informed that should a bleeding event occur there would be no antidote to stop it.

Pradaxa Bleeding Risk

Pradaxa has been the subject of numerous studies as even the U.S. Food and Drug Administration has recently taken an interest in the safety of the blood thinner.

In a study published in the online journal JAMA Internal Medicine, a group of researchers studied 9,400 atrial fibrillation patients who were taking either Pradaxa or the more traditional anticoagulant Warfarin.

The study found that consumers taking the new blood thinner had a higher overall risk of experiencing a major bleed. Researchers also reported that while the bleeding sites differed, Pradaxa users had a greater risk of stomach and intestinal bleeds when compared to Warfarin (Coumadin) consumers.

In another study performed by researchers at Johns Hopkins Bloomberg School of Public Health and George Washington University more than 46,000 patients were analyzed. The study compared the internal bleeding risks of the latest blood thinners including Pradaxa and Xarelto to Warfarin.

Researchers found that the new anticoagulants Pradaxa and Xarelto carry a high risk of internal bleeding especially when compared to Warfarin. The study determined that the overall risk of internal bleeding that the new-generation of blood thinners carry outweighs the potential benefits.

Pradaxa Complications

Pradaxa was manufactured by Boehringer Ingelheim Pharmaceuticals and was “fast tracked” through the FDA approval process, meaning there was only one clinical trial before it was released on the U.S. market.

While all blood thinner carry some risk of internal bleeding, Pradaxa consumers who have filed lawsuits against the manufacturer claim they were unaware that a Pradaxa antidote does not exist.

Unlike Warfarin consumers who can be given a dose of vitamin K to get bleeding under control; Pradaxa users who experience internal bleeding must suffer through multiple blood transfusions and lengthy hospital stays as the only way to stop Pradaxa internal bleeding is to get the medication out of the system.

Medical experts have suggested that Pradaxa manufacturers may have erred in claiming that the medication does not require blood monitoring. Physicians state that regular blood testing may actually help doctors determine who has an increased bleeding risk.

Pradaxa Bleeding Lawsuits

Thousands of Pradaxa lawsuits have been filed against manufacturer Boehringer Ingelheim Pharmaceuticals. In general, Pradaxa internal bleeding lawsuits allege that the manufacturer downplayed the risk of internal bleeding and did not fully warn that should internal bleeding occur there would be no reversal agent to get it under control.

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 should file a lawsuit as an individual or if it would be better for you to join a Pradaxa class action lawsuit. Families who lost a loved one due to Pradaxa side effects may also be able to file a wrongful death lawsuit.