New blood thinners seemed to be all the rage a few years ago, but more reports of internal bleeding from Pradaxa are tempering that excitement.

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

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 one or both upper heart chambers function erratically.

Blood clotting occurs more frequently in people who have atrial fibrillation because the heart beats so fast and erratically that the blood isn’t pushed completely out of the heart, which 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 are due to the condition are more likely to be severe, with a higher incidence of death and disability.

Internal Bleeding from Pradaxa

Pradaxa works by stopping the action of thrombin, a clotting enzyme. While this action prevents blood clots from forming, the drug has also led to internal bleeding from Pradaxa.

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 are one of the top drug-related adverse events it receives in overall reports.

Of 2011’s FDA-reported adverse events with Pradaxa, 25 percent involved patients 84 years of age or older, who are also more likely to have reduced kidney function.

Patients experiencing even a slight reduction in kidney function had Pradaxa blood levels that were 50 percent higher than other patients, according to Pradaxa studies.

Finally in 2012, Boehringer Ingelheim warned that there was no reversal agent available at that time that could reverse internal bleeding from Pradaxa.

Inexplicably, the company allegedly had developed an antidote even before Pradaxa was approved to be sold in the United States, but did not seek approval of the antidote until years later. Boehringer Ingelheim’s Praxbind went on the market in the fall of 2015.

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 every one to four weeks to ensure optimal levels are 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.

While the need for blood monitoring might be inconvenient, Coumadin might be safer for patients who are endangered by the “one size fits all” recommended dosing of Pradaxa.

If you or someone you know has experienced internal bleeding from Pradaxa, you could qualify for participation in a Pradaxa lawsuit.