Doctors have warned of bleeding side effects of Pradaxa for years.

The FDA approved Pradaxa for use as an anticoagulant in October 2010. Often called a blood thinner, anticoagulants like Pradaxa reduce the chances of a stroke by reducing blood clotting mechanisms.

Bleeding Side Effects of Pradaxa Can Affect Stomach, Brain

When a blood vessel wall is damaged, it can leak blood into surrounding tissues, creating a hematoma. Bleeding side effects of Pradaxa 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.

In 2011, a study using mice confirmed the connection between Pradaxa and hematoma expansion. Stroke online magazine by the American Heart Association provided details of what happened when mice received Pradaxa.

Researchers from University Heidelberg in Germany observed intracerebral hematoma expansion during the first three hours after introducing Pradaxa. A higher dose of Pradaxa increased the hematoma volume substantially within that three-hour period.

This meant the Pradaxa was causing increased bleeding into the hematoma.

Pradaxa works by blocking thrombin, a clotting protein. When this clotting protein is not working well, side effects include bruising, minor bleeding, indigestion and heartburn.

When too much of the clotting protein is halted from doing its job, gastrointestinal bleeding can occur.

Bleeding Side Effects of Pradaxa Became Known Early On

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.

Pharmaceutical company Boehringer Ingelheim finally warned in 2012 that Pradaxa bleeding was irreversible and that there was no reversal antidote available at that time.

However, the company allegedly had developed 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.

Praxbind finally was introduced in the fall of 2015, but it was too late for many patients.

‘One Dose Fits All’ Has Flaws

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 dose is very high initially, that factor alone can raise the risk of bleeding side effects of Pradaxa, explains Dr. Curt Furberg, 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 says that Pradaxa’s one-dose-fits-all might effectively prevent strokes in some patients, but the dose is too low to be effective in other patients.

In others yet, the dose can be too high, which means an increased risk of bleeding side effects of Pradaxa for those patients.

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 taken Pradaxa and experienced bleeding issues, you could be eligible for compensation through a personal lawsuit or joining a class action lawsuit.