Serious Pradaxa bleeding can lead to severe injuries and in some cases, even death.

FDA-approved in 2010, Pradaxa is a new blood thinner (anticoagulant) made by Boehringer Ingelheim Pharmaceuticals.

An investigation has begun into serious Pradaxa bleeding issues experienced by patients who took the blood thinner designed to reduce the incidence of blood clots. Pradaxa blocks thrombin, a clotting protein. Minor side effects can include easy bruising, minor bleeding, indigestion, and heartburn.

When Pradaxa inhibits too much thrombin, hemorrhaging can occur.

Serious Pradaxa Bleeding Problems Known Early On

More than 255 patients suffered fatal bleeding from Pradaxa with a month of drug’s availability. In 2011, 540 more patients died from serious Pradaxa bleeding episodes.

In 2012, Boehringer Ingelheim warned that hemorrhaging from Pradaxa may not be reversible; no antidote existed at the time.

Cases included gastrointestinal bleeding and brain bleeding.

Pradaxa was marketed as a superior and safer alternative to anticoagulant Coumadin (warfarin), which has been on the market for over 60 years. Coumadin is recognized as comparatively safe because patients must undergo blood monitoring to maintain a therapeutic level in their blood.

Additionally, Coumadin’s blood-thinning effects can be stopped in the event of internal bleeding, surgery, or an accident by the administration of a dose of vitamin K. All emergency room doctors are trained to know the protocol for Coumadin’s antidote.

No antidote was available for Pradaxa until Boehringer Ingelheim introduced Praxbind in 2015. This antidote allegedly was developed as a proper reversal agent even before Pradaxa was FDA-approved in the United States. The company has not explained why there was a delay in seeking Praxbind’s approval.

Serious Pradaxa Bleeding Investigation Now Underway

Boehringer Ingelheim settled nearly 4,000 Pradaxa lawsuits in May 2014 when the company agreed to pay $650 million but admitted no wrongdoing.

A new investigation into serious Pradaxa bleeding issues is underway for patients or their loved ones who have experienced injuries due to the medication. Boehringer Ingelheim has faced accusations that the company did not warn patients or their doctors of the drug’s bleeding risks.

Even though Pradaxa is taken by patients who need to reduce their blood’s clotting action to prevent strokes, the anticoagulant allegedly has a higher than anticipated risk of serious Pradaxa bleeding problems than it should have.

Among the symptoms of internal bleeding are bruising without a known reason, unstoppable and frequent nosebleeds, gums that bleed, discolored urine, darkened stools, and coughing up or vomiting blood.

When a patient endures serious Pradaxa bleeding, the only way to stop it is to flush the body of the drug through dialysis. This process can take hours. A patient might need several blood transfusions and still might not survive the ordeal.

Pradaxa class action lawsuits and individual Pradaxa lawsuits have been filed in courts across the nation by patients and their families who allege they were misled regarding the drug’s safety and effectiveness.