A recent study comparing Pradaxa to the more traditional anticoagulant Warfarin (Coumadin) suggests that Pradaxa consumers may face an increased risk of internal bleeding.

In a Pradaxa study published in the Journal of the American Medical Association’s Internal Medicine, researchers examined the medical records of more than 9,000 patients who were taking a blood thinner between 2010 and 2011.

The study determined that the Pradaxa bleeding risk was greater than in those patients taking Warfarin. Warfare users suffered bleeding 27 percent of the time compared to 33 percent for Pradaxa users. In addition, 17 percent of Pradaxa patients experienced a stomach or intestinal bleeding event compared to 10 percent of Warfarin patients.

Other Pradaxa bleeding studies have found similar results. In a study that followed more than 46,000 patients taking either the new anticoagulants Pradaxa or Xarelto compared to those taking Warfarin, researchers from Johns Hopkins Bloomberg School of Public Health and George Washington University found that consumers taking Pradaxa or Xarelto had a higher risk of internal bleeding when compared to Warfarin.

The researchers in this particular Pradaxa study indicated that the bleeding risks of the new anticoagulant outweighed any potential benefits of taking the medication.

Pradaxa Complications

Pradaxa was the first blood thinner on the market since Warfarin, which dominated for more than 50 years. The anticoagulant 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.

Pradaxa was approved in 2010 as a blood clot treatment and as a way to help reduce the risk of stroke in atrial fibrillation patients. Boehringer Ingelheim Pharmaceuticals marketed the latest blood thinner as more convenient than Warfarin as the manufacturer assured patients that they would no longer have any dietary restrictions or suffer through regular blood testing.

However, since its release, thousands of adverse event reports have been reported to the U.S. Food and Drug Administration claiming that Pradaxa has caused serious internal bleeding complications. Hundreds of these reports claim the anticoagulant lead to a hemorrhage-related death.

Pradaxa Internal Bleeding

While all blood thinners carry some risk of internal bleeding, many Pradaxa consumers who have since filed lawsuits against the drug’s manufacturer claim they were unaware that should a bleeding event occur there would be no way to stop it as a Pradaxa antidote does not exist.

Warfarin consumers who experience a bleeding event can be given a dose of vitamin K in order to get it under control. Pradaxa patients who suffer excessive internal bleeding must go through multiple blood transfusions and lengthy hospital stays since the only way to stop Pradaxa bleeding is to get the medication out of the system.

Experts have indicated that Pradaxa manufacturers may have erred by claiming that the anticoagulant does not require blood monitoring. They claim that regular blood testing may actually help physicians determine who is at an increased internal bleeding risk.

Pradaxa Lawsuits

Thousands of Pradaxa lawsuits have been filed so far that accuse Boehringer Ingelheim Pharmaceuticals of intentionally hiding the risk of internal bleeding complications from consumers. In general, plaintiffs also claim they were not fully warned that should a Pradaxa bleeding event occur there would be no reversal agent to get it under control.

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