The blood thinning drug Pradaxa is often prescribed to aid patients with clotting risks, but many reports of Pradaxa bleeding injuries have caused patients, the medical community, and the FDA to question its safety.

Pradaxa is an anticoagulant that is a thrombin inhibitor. The drug attaches itself to the main clotting mechanism of the blood, thrombin. This keeps the blood from clotting as it normally would, reducing the risk of deadly blood clots in those with high risk.

A blood clot is deadly if it travels to the brain, heart or lungs. Many people who have lower body extremity surgery such as a hip or knee replacement are at an increased risk for blood clots.

Some patients are prescribed Pradaxa or other thrombin inhibitors if they have a condition known as atrial fibrillation. In a patient with atrial fibrillation, blood pools in a chamber of the heart. If let untreated, the stagnant blood may form a blood clot and travel to the brain instigating a stroke.

If this happens, the blood clot blocks part of the blood flow to certain parts of the brain. This can either be deadly or leave the patient severely injured.

Because of the nature of an anticoagulant, this drug can also inadvertently cause Pradaxa bleeding injuries that cannot be reversed.

Pradaxa was approved in 2010 for use as a blood thinner several years before a reversal agent was available. It was only in 2015 that Praxbind, the reversal agent for Pradaxa, was able to be administered in the case of severe Pradaxa bleeding injuries.

With Pradaxa or other blood thinning medications, the blood has difficulty clotting when it actually needs to do so. So some fatal Pradaxa bleeding injuries have included gastrointestinal hemorrhaging.

The more popular anticoagulant on the market before Pradaxa and other thrombin inhibitors made their debut was a drug called warfarin, or Coumadin. Warfarin required frequent blood monitoring and diet changes, so patients often opted for the newer drugs as they came available.

However, warfarin had an adverse bleeding event reversal agent readily available. Vitamin K, when administered to someone on warfarin and experiencing severe bleeding, is able to reverse the effects of warfarin.

Warfarin works by reducing the activity of vitamin K, which is needed for the body to form clots. When vitamin K is given to a patient on warfarin who is hemorrhaging, the body is able to form clots again.

No such antidote was available for Pradaxa patients for several years. Many people suffered dangerous and fatal Pradaxa bleeding injuries for years before a reversal agent was available.

Pradaxa Bleeding Injuries

In the first years of use, hundreds of deaths were reported to the FDA in relationship to Pradaxa bleeding injuries that could not be reversed. By 2014, thousands of lawsuits had been filed against the manufacturer, Boehringer Ingelheim, and the company was ordered to pay $650 million to settle 4,000 of those lawsuits.

If you or someone you love has experienced dangerous or deadly Pradaxa bleeding injuries, you may benefit from speaking to an experienced attorney and you may be entitled to legal compensation.