Pradaxa hemorrhaging has been a serious health issue since it went on the market.

The FDA approved Pradaxa for use as an anticoagulant in October 2010. Often called a blood thinner, anticoagulant medicines reduce the chances of a stroke by reducing blood clotting mechanisms; however, they also increase the risk of bleeds.

Pradaxa Hemorrhaging Can Affect Stomach, Brain

When a blood vessel wall is damaged, it can leak blood into surrounding tissues, creating a hematoma. Pradaxa hemorrhaging 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.

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.

Pradaxa hemorrhaging, including gastrointestinal bleeding, can occur when too much of the clotting protein is kept from doing its job.

Pradaxa Hemorrhaging Issues 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 warned in 2012 that Pradaxa hemorrhaging 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 placed on the market in the fall of 2015, but it was too late for many patients.

In May 2014, Boehringer Ingelheim agreed to pay $650 million to settle 4,000 state and federal Pradaxa lawsuits. The company did not admit any wrongdoing when they agreed to the settlement.

“We continue to stand resolutely behind Pradaxa and believed from the outset that the plaintiffs’ claims lacked any merit,” Andreas Neumann, head of the Legal Department and general counsel for Boehringer Ingelheim worldwide, said in a statement.

“Notwithstanding our strong belief that we would prevail in these lawsuits, this settlement allows our company to avoid the distraction and uncertainty of protracted litigation over years and years.”

If you have taken Pradaxa and experienced Pradaxa hemorrhaging, you could be eligible for compensation through a class action lawsuit. A specialized lawyer can answer any questions you may have.