Internal bleeding and Pradaxa became a known health problem soon after patients began taking the new blood thinner.

Approved by the FDA in October 2010, Pradaxa reduces the chances of having a stroke by controlling the blood’s clotting mechanisms. Specifically, Pradaxa is in a class of drugs known as direct thrombin inhibitors, which means Pradaxa blocks the blood’s main clotting protein, thrombin.

Less severe Pradaxa side effects can include indigestion, heartburn, easy bruising and minor bleeding.

Patients suffering severe internal bleeding and Pradaxa side effects can experience gastrointestinal bleeding or brain hemorrhaging. These side effects mean too much of the thrombin clotting protein is inhibited and the blood can’t clot at all.

Problems from Internal Bleeding and Pradaxa Known in First Month

By the time Pradaxa had been on the market for a year, 260 patients had died from internal bleeding and Pradaxa. A total of 540 patients lost their lives in 2011.

In 2012, Pradaxa maker Boehringer Ingelheim issued a warning that internal bleeding and Pradaxa could be unstoppable. No reversal agent was available at the time.

Pradaxa also has been linked to hematoma expansion. When a blood vessel wall is thinned and damaged, blood can leak into tissues where it doesn’t belong. The resulting hematoma can be tiny, or it can be large enough to cause swelling, pain and pressure.

Pradaxa allegedly increases the risk for hematomas in the brain to expand, which is especially dangerous because the skull is enclosed and is unable to expand like our skin can. A brain hematoma can cause extreme pain and impair brain function.

Pradaxa Alleged Superiority over Coumadin

Pradaxa was marketed as a superior blood thinner to Coumadin (warfarin), which has been used for more than 60 years.  In a case of surgery or an accident causing unexpected bleeding, Coumadin’s anticoagulating effects can be reversed by a doctor administering an IV dose of vitamin K. Coumadin requires regular blood monitoring to determine how quickly the blood clots.

Pradaxa does not require monitoring, but some doctors and researchers believe the dosages should be monitored.

Pradaxa has been marketed as a “one dose fits all” drug. But research has indicated that a certain dose given to one patient might be effective, but that same dose given to a different patient might lead to bleeding problems. Still another patient might not see therapeutic effects at all from that same dose because it is too low of a dose for that patient.

From its introduction in October 2010 until March 2011, Pradaxa’s label did not include complete information regarding dose recommendations and a patient’s weight.

Boehringer Ingelheim agreed to a $650 million settlement in May 2014 in order to settle 4,000 state and federal lawsuits. While Boehringer Ingelheim did not admit any wrongdoing, the company did introduce a Pradaxa antidote in February 2015. Praxbind was available to patients in the fall of 2015, an entire five years after the dangerous drug had led to the death of and injuries of thousands of patients.