Pradaxa hemorrhaging has become a potentially life-threatening issue for thousands of patients who have taken the anticoagulant.

Pradaxa belongs to a class of drugs known as New Oral Anticoagulants (NOACs) and works by interfering with the clotting protein, thrombin.

FDA-approved in 2010, Pradaxa (dabigatran) was touted as a superior blood thinner to Coumadin (warfarin). Pradaxa required no change in diet and patients didn’t need blood tests as often. Drug maker Boehringer Ingelheim advertised Pradaxa as a one-dose-fits-all medication. Some patients, however, have reported Pradaxa hemorrhaging.

Dr. Curt Furberg disagrees with the one-dose-fits-all claim. He is the Institute for Safe Medication Practices’ medical advisor and a professor emeritus of public health sciences at Wake Forest School of Medicine. He argues that Pradaxa has a wide range of clot-preventing action that varies from patient to patient, according to U.S. News.

He says that while one dose may effectively prevent strokes in one patient, that same dose might be too low to be effective at all in another patient. In some patients, the identical dose might be so high that the patient exhibits Pradaxa hemorrhaging.

As soon as the drug was introduced to the market, Pradaxa hemorrhaging became an apparent and dangerous problem. Within a month of its release, 260 patients fatally bled out from the blood thinner. In 2011, another 540 Pradaxa patients lost their lives.

Patients died of Pradaxa hemorrhaging, including gastrointestinal bleeding and brain bleeding, because too much thrombin was blocked, and the blood could not clot enough to get the bleeding under control.

In contrast, if the patients had taken Coumadin instead of Pradaxa, they could have received an IV dose of vitamin K to stop the anti-clotting effects of Coumadin. In fact, every emergency room physician in the U.S. knows how to flush Coumadin out of the body with vitamin K.

Until Boehringer Ingelheim introduced an antidote called Praxbind in 2015, there was no reversal agent for Pradaxa.

For years before Praxbind was released, doctors had to flush Pradaxa by having the patient undergo long hours of dialysis and possibly several blood transfusions. In hundreds of cases, patients still died.

The FDA issued a warning in December 2011 to notify Pradaxa patients that unusually serious, uncontrollable internal bleeding was a potential risk of the blood thinner, even more so than with other anticoagulants. Patients were warned to look for bruises that appeared without a known reason, frequent nosebleeds, gums bleeding, discolored urine, red or black bowel movements, coughing up blood or even, vomiting blood.

Pradaxa Hemorrhaging Sparks Lawsuits

Patients who have experienced internal bleeding, kidney bleeding, gastrointestinal bleeding, heart attack, or a stroke after taking Pradaxa could qualify to participate in a class action lawsuit. Loved ones of patients who have died after taking Pradaxa may also be eligible.

Several lawsuits claim Boehringer Ingelheim knew the drug could cause severe and uncontrollable bleeding that could prove fatal, but never warned patients or doctors of the risks of Pradaxa hemorrhaging. In fact, it wasn’t until 2012 that the drug company finally warned that Pradaxa hemorrhaging was irreversible.