Medical experts report that the blood thinner Pradaxa has caused more than 500 deaths and more than 1,000 near fatalities due to uncontrollable internal bleeding complications.

Pradaxa was the first anticoagulant to be approved of since Warfarin (Coumadin) which dominated the blood thinner market for 50 years. However, since its release in 2010 Pradaxa has been at the center of controversy as consumers have reported serious bleeding events, a side effect many claim they were unaware of.

What is Pradaxa?

Pradaxa was FDA approved to reduce the risk of stroke in patients who have been diagnosed with atrial fibrillation, it was later 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. More than 9 million Americans have been prescribed Pradaxa in just a few short years.

The medication was marketed by Boehringer Ingelheim Pharmaceuticals as a more convenient blood thinner when compared to Warfarin. It gained in popularity quickly due to claims that patients were not required to endure regular blood testing or have any dietary restrictions. However, unlike Warfarin there is currently no antidote should a Pradaxa bleeding event occur.

Warfarin (Coumadin) consumers who experience excessive bleeding can be given a dose of vitamin K in order to get it under control. With Pradaxa, patients who suffer from internal bleeding have to suffer through multiple blood transfusions as the only way to stop the bleeding is to get the medication out of their system.

Thousands of consumers claim they were unaware that should a Pradaxa internal bleeding event occur there was no reversal agent to help them.

Recent Pradaxa Study

Researchers at Johns Hopkins Bloomberg School of Public Health and George Washington University studied the internal bleeding risks of the “new generation” of blood thinners when compared to the traditional Warfarin. Researchers analyzed more than 46,000 patients who were prescribed either Pradaxa, Xarelto or Warfarin over the course of several months.

The Pradaxa study found that the risks of internal bleeding events were overall higher in the new generation blood thinners when compared to Warfarin. Researchers determined that the increased Pradaxa bleeding risk outweighed any potential benefits.

Pradaxa Lawsuits

Thousands of lawsuits have been filed accusing Pradaxa’s manufacturer of knowing of the uncontrollable internal bleeding risks linked to the medication but intentionally hiding the information from consumers. Plaintiffs filing Pradaxa bleeding lawsuits also allege the manufacturer did not fully warn consumers that if a bleeding event occurs there is no antidote to stop it.

The number of Pradaxa lawsuits continues to grow as more patients allege Boehringer Ingelheim Pharmaceuticals deliberately downplayed the risks of internal bleeding. More than 4,000 Pradaxa lawsuits have been settled so far for a total of $650 million.

Pradaxa’s manufacturer has acknowledged that a Pradaxa bleeding reversal agent is needed and is in the process of getting a Pradaxa antidote approved. 

If you suffered from Pradaxa internal bleeding contact an attorney to find out if you have legal claim.