For many patients, Pradaxa internal bleeding side effects are quickly outweighing the benefits of the anticoagulant.

Thousands of Pradaxa users have suffered serious bleeding side effects, including gastrointestinal, rectal and brain bleeding.

The FDA approved Boehringer Ingelheim’s Pradaxa as an anticoagulant in October 2010.

Commonly called a blood thinner, the drug reduces the chances of a stroke in patients with atrial fibrillation, a type of irregular heartbeat that occurs when or both upper heart chambers function erratically.

Blood clotting occurs more frequently in people who have atrial fibrillation, which leads to them having an increased risk of stroke that is five times that of the general population.

Atrial fibrillation itself is not life-threatening, but the strokes that are due to the condition are more likely to be severe, with a higher incidence of death and disability.

Pradaxa Internal Bleeding Side Effects

While Pradaxa has prevented blood clots from forming, the drug has also led to Pradaxa internal bleeding side effects, such uncontrollable bleeding that patients have died.

At least 260 people had fatally bled out after taking Pradaxa by November 2010. Another 540 patients using Pradaxa died in 2011.

The FDA states that Pradaxa internal bleeding side effects is one of the top drug-related adverse events it receives in overall reports.

It wasn’t until 2012 that Boehringer Ingelheim warned that Pradaxa-induced bleeding was irreversible and that there was no reversal agent 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 victims.

Pradaxa internal bleeding side effects can include intracerebral hemorrhage (brain bleeding) and hematoma expansion. When a blood vessel wall or vein is damaged, it can leak blood into surrounding tissues. The hematoma can be small or it can be large and cause swelling and pain.

Hematomas in the brain are the most dangerous because the skull is enclosed and cannot expand like skin can. When a hematoma develops in the brain, it increases pressure and impairs brain function.

A 2011 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 were given Pradaxa (dabigatran-etexilate).

Researchers observed intracerebral hematoma expansion during the first three hours. A higher dose of Pradaxa increased the hematoma volume substantially within a three-hour period.

Boehringer Ingelheim has been accused of failing to warn of the link between Pradaxa and intracerebral hemorrhage.

Pradaxa Claimed Greater Safety

The drug manufacturer claimed to doctors and patients that Pradaxa was so safe that it didn’t require monitoring.

Pradaxa marketers were attempting to prove the drug’s superiority over the previous go-to blood thinner medication, Coumadin, which requires blood monitoring.

Coumadin has been used for more than 50 years, and most side effects can be controlled through monitoring and the use of vitamin K, which minimizes bleeding problems.

The misperception that Pradaxa was safer than other anticoagulants may have led to an abundance of patients becoming ill and dying from Pradaxa internal bleeding side effects.