The risk of suffering adverse effects of Pradaxa is a trade-off that patients make to enjoy the conveniences associated with the new anticoagulant.

Originally approved by the FDA in 2010, Pradaxa is frequently prescribed to patients with atrial fibrillation to help manage the risk of stroke associated with that condition.

The irregular heartbeat associated with atrial fibrillation can cause blood to become stagnant in certain parts of the circulatory system, giving it a chance to clot.

Such clots may come loose into the bloodstream and travel to the brain, where they can cause a stroke. Anticoagulants like Pradaxa prevent those clots from forming in the first place.

For decades, warfarin was the go-to anticoagulant medication with no significant challengers on the market. But warfarin came with certain drawbacks: patients must submit to certain dietary restrictions, and they have to get their blood tested on a regular basis to ensure proper dosage.

Pradaxa was designed to avoid those drawbacks. It works by inhibiting the activity of thrombin, an enzyme that promotes blood clotting. With thrombin less active, clots that could cause stroke or pulmonary embolism are less likely to form.

But the body’s natural clotting mechanism does have an important function: clotting is a built-in mechanism that helps stop excessive bleeding once it starts.

So while patients taking Pradaxa do enjoy a significantly reduced risk of stroke and embolism, the same mechanism that reduces that risk exposes them to a risk of excessive bleeding.

Adverse Effects of Pradaxa Reported to FDA

In 2011, the first year after Pradaxa was approved, reports to the FDA of adverse effects of Pradaxa surpassed those associated with warfarin.

That same year, the Institute for Safe Medication Practices reported that Pradaxa was linked to more injuries and deaths than any of the hundreds of other drugs the institute reviewed.

This bleeding risk is not unique to Pradaxa; all anticoagulants pose this risk for patients. The availability of an antidote can be a significant difference among these medications: some have one, and others don’t.

For as long as warfarin dominated the market, patients had the benefit of being able to control its anticoagulant effect by administering vitamin K.

But when the new oral anticoagulants like Pradaxa were released, they had no such antidote available. Patients simply had to live with the risk of the adverse effects of Pradaxa.

It wasn’t until just recently that the FDA finally approved Praxbind, an antidote for Pradaxa. But for the first several years that Pradaxa was on the market, thousands of patients reported adverse effects of Pradaxa that could have been better controlled had an antidote been available.

Thousands of patients who suffered bleeding injuries while on Pradaxa have taken to the legal system to seek compensation. In May 2014, Pradaxa manufacturer Boehringer Ingelheim settled around 4,000 Pradaxa lawsuits for a total of $650 million.

That settlement does not stop new claims from being filed, however. Pradaxa is still on the market, and patients who suffer excessive bleeding injuries while on Pradaxa can still consult a knowledgeable Pradaxa attorney to understand their legal options.