Pradaxa uncontrollable bleeding is a possible adverse effect of this new blood thinner.

The FDA approved Pradaxa for use as an anticoagulant in October 2010. Often called a blood thinner, Pradaxa reduces the chances of a stroke by interfering with thrombin, a clotting protein.

Pradaxa Uncontrollable Bleeding Can Effect Brain, Stomach

Pradaxa can make bleeding injuries worse. When a blood vessel wall is damaged, it can leak blood into surrounding tissues, creating a hematoma. When Pradaxa causes bleeding, it can include intracerebral hemorrhage (brain bleeding) and hematoma expansion. Hematomas in the brain are dangerous because the skull is enclosed and cannot expand like skin can. When a hematoma develops in the brain, pressure builds, causing intense pain and impairing brain function.

Pradaxa uncontrollable bleeding occurs when the medication blocks too much thrombin, depleting the blood’s ability to clot to a dangerous degree. At that point, gastrointestinal bleeding can occur.

Manufacturer Allegedly Knew Pradaxa Uncontrollable Bleeding Possible

Pharmaceutical company Boehringer Ingelheim has been accused of knowing that Pradaxa uncontrollable bleeding was a possibility, but not sharing that information with the medical community or with consumers.

Within a month of the drug’s release on the market, 260 patients had fatally bled out after taking Pradaxa. An additional 540 patients died in 2011 after taking it.

Boehringer Ingelheim finally added a warning in 2012 that there was no antidote available that could slow or stop Pradaxa uncontrollable bleeding.

The company allegedly had produced an antidote even before Pradaxa was approved to be sold in the United States. Boehringer Ingelheim didn’t seek approval of Praxbind, the antidote for Pradaxa, until February 2015. Introduced in the fall of 2015, Praxbind was too late for hundreds of patients who had succumbed to Pradaxa uncontrollable bleeding.

The drug manufacturer assured doctors and patients that Pradaxa was so safe that it didn’t require monitoring, a big selling point because its main competitor, Coumadin, requires blood tests to ensure a therapeutic level is maintained.

Pradaxa marketers attempted to prove the drug was superior to Coumadin (warfarin), which has been used for more than 50 years. Vitamin K is the antidote for Coumadin’s blood-thinning properties.

ISMP Doctor Offers Pradaxa Opinion

Dr. Curt Furberg is a medical advisor to the Institute for Safe Medication Practices (ISMP), a nonprofit organization dedicated to educating the healthcare community and the public about medication safety.

Speaking to U.S. News, Dr. Furberg, a professor emeritus of public health sciences at Wake Forest School of Medicine, says that Pradaxa has a wide variation of clot-preventing effects, depending upon the patient.

Pradaxa comes as only a single-dose medication in the United States, but it is approved in two different doses in Europe. Dr. Furberg says because the single dose is very high initially, that factor alone can raise the risk of bleeding.

Pradaxa is marketed as a one-dose-fits-all medication. But Dr. Furberg says that Pradaxa might effectively prevent strokes in some patients, but the dose is too low to be effective in other patients. In yet other patients, the dose can be too high, which means an increased risk of Pradaxa uncontrollable bleeding exists for those patients.

If you have experienced Pradaxa uncontrollable bleeding after taking the medication, you could be eligible for compensation through legal representation.