Pradaxa users have an 85 percent increased risk of gastrointestinal bleeding compared to patients taking Warfarin (Coumadin), according to a study published in the Journal of the American Medical Association, Internal Medicine.

The Pradaxa study followed patients who were recently diagnosed with atrial fibrillation between Oct. 1, 2010 and Oct. 31, 2011 and started taking either Pradaxa (dabigatran) or Warfarin. Researchers continued to analyze the AF patients until they discontinued or switched blood thinners.

Pradaxa and Warfarin patients were further separated into subgroups to find if age and medical history also played a factor with increased bleeding events. According to the JAMA study, Pradaxa users had an overall increased bleeding risk of 30 percent, a 58 percent greater risk of a major bleeding, and a 85 percent increased risk of gastrointestinal bleeding when compared to Warfarin users.

Researchers also determined that Pradaxa patients with chronic kidney disease, as well as African Americans, had an even higher risk of a major bleeding event.

New Blood Thinner Pradaxa

For more than 50 years, Warfarin (Coumadin) dominated the anticoagulant market. In 2010, the U.S. Food and Drug Administration approved Pradaxa as an alternative to treat atrial fibrillation as well as blood clots.

Pradaxa manufacturer Boehringer Ingelheim spent $464 million to market the new anticoagulant around the world. Pradaxa sales are expected to eventually bring in $10 billion a year in the U.S. alone.

The medication was marketed as more convenient than Warfarin because there are no dietary restrictions and no regular blood testing required. However, it didn’t take long before Pradaxa patients began reporting adverse bleeding events to the FDA.

Pradaxa Bleeding Side Effects

Since its release, thousands of Pradaxa consumers have claimed the medication caused life-threatening internal bleeding. The drug has also been named as the cause of death in more than 500 patients.

Individuals who suffered a Pradaxa bleeding event claim that they were unaware there was no reversal agent. Unlike Coumadin users who can be given a dose of vitamin K to get a bleeding event under control, Pradaxa patients have to undergo blood transfusions in order to get the medication out of their system.

Last month, The U.S. Food and Drug Administration granted accelerated approval for Praxbind (idarucizumab) which is the first Pradaxa bleeding antidote that will be available to patients. However, those who have filed Pradaxa lawsuits claim the reversal agent came too late.

Pradaxa Lawsuits

Thousands of consumers have filed Pradaxa lawsuits against the drug manufacturer over claims that Boehringer Ingelheim Pharmaceuticals placed Pradaxa sales over patient safety by failing to warn of the serious internal bleeding risk.

In 2014, Pradaxa’s manufacturer agreed to settle 4,000 Pradaxa lawsuits for $650 million, which awarded each plaintiff $162,500.

If you experienced Pradaxa internal bleeding, you may have legal claim. Contact a Pradaxa attorney to find out your legal options.