Why does Pradaxa cause bleeding? The popular new anticoagulant works by blocking a particular clotting protein called thrombin.

The FDA approved Pradaxa for use as an anticoagulant in October 2010. Often called a blood thinner, the medicine reduces the chances of a stroke.

But common Pradaxa side effects include bruising, minor bleeding, indigestion and heartburn.

Pradaxa Causes Bleeding of Brain, Stomach

When Pradaxa blocks too much thrombin, depleting the blood’s ability to clot to a dangerous degree, gastrointestinal bleeding can occur.

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 and impairs brain function.

Manufacturer Allegedly Knew Pradaxa Caused Bleeding

Pharmaceutical company Boehringer Ingelheim has been accused of knowing that Pradaxa caused bleeding early on. Many anticoagulants cause bleeding, but the risks vary.

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 warned in 2012 that Pradaxa caused bleeding that was irreversible and that there was no reversal antidote available at that time.

Still, 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/reversal agent, until February 2015.

Introduced in the fall of 2015, Praxbind was too late for hundreds of patients.

How Does Pradaxa Cause Bleeding?

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.

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 dosages in Europe. Because the single does is very high initially, that factor alone can raise the risk of bleeding, he explains.

Although Pradaxa is marketed as a one-dose-fits-all medication, Dr. Furberg says that Pradaxa might effectively prevent strokes in some patients, but the dose is too low to be effective in other patients.

Contrarily, for other patients the dose can be too high, which means an increased risk of Pradaxa bleeding problems for those individuals.

The ISMP analyzed the FDA’s nearly 34,765 adverse drug event reports for blood thinners administered orally last year. The reports included almost 3,000 deaths and more than 9,500 adverse events that required hospitalization.

If you have experienced Pradaxa-caused bleeding after taking the medication and suffered injury, you could be eligible for compensation through a class action lawsuit. Specialized Pradaxa attorneys can help decide if a lawsuit is right for you.