Thousands of patients have suffered serious side effects of Pradaxa, a blood thinning medication. Life-threatening side effects, including gastrointestinal, rectal and brain bleeding, are all too common.

The FDA approved Boehringer Ingelheim’s Pradaxa as an anticoagulant in October 2010.  Pradaxa reduces the chances of a stroke in patients with atrial fibrillation, a type of irregular heartbeat that occurs when one or both upper heart chambers function erratically.

Blood clotting occurs more frequently in people who have atrial fibrillation because the blood tends to pool at the bottom of the heart’s chamber. This leads to 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 occur as a result of the condition are more likely to be severe, with a higher incidence of death and disability.

Side Effects of Pradaxa

Because Pradaxa side effects can induce such severe internal bleeding that patients can die, Pradaxa is a dangerous drug.

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

In 2012, Boehringer Ingelheim finally warned that side effects of Pradaxa included irreversible bleeding and that there was no reversal agent available at that time.

In February 2015, Boehringer Ingelheim sought FDA approval of Praxbind, the antidote/reversal agent. The company allegedly had developed Praxbind even before Pradaxa was approved to be sold in the United States. No explanation as to why the company delayed seeking approval for Praxbind has ever been offered.

Pradaxa internal bleeding side effects can include gastrointestinal or rectal bleeding, and bleeding of the brain and hematoma expansion. A damaged blood vessel wall can cause blood to leak into surrounding tissues. This 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. A brain hematoma causes severe pressure and impairs brain function.

Stroke online magazine by the American Heart Association provided details of what happened when mice were given Pradaxa in a 2011 study that linked Pradaxa with hematoma expansion. Researchers observed brain hematoma expansion during the first three hours. A higher dose of Pradaxa increased the hematoma volume substantially within that three-hour period.

Boehringer Ingelheim has been accused of failing to warn that side effects of Pradaxa can include brain bleeds.

Pradaxa’s Superior Safety Claim Doesn’t Hold Up

Pradaxa was marketed to the healthcare industry and to consumers as a drug that was so safe, no monitoring was required.

Pradaxa marketers were attempting to prove the drug’s superiority over the previous go-to blood thinner medication Coumadin, which requires blood monitoring to ensure a therapeutic level is maintained. 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 Coumadin led to an abundance of patients becoming lulled into a false sense of security, and a great number of Pradaxa injuries.

If someone you love has suffered serious bleeding side effects of Pradaxa, you could have a legal case against Boehringer Ingelheim.