Pradaxa gained FDA approval for an additional medical use: treating blood clots to the heart.

Boehringer Ingelheim Pharmaceuticals can now legally advertise Pradaxa for this additional purpose and can now reach out to a wider target market.

Thromboprophylaxis is the act of preventing a coronary thrombosis (blood clots of the heart), which aligns with Pradaxa’s anticoagulant mechanism. As a blood thinner, Pradaxa is typically prescribed to patients with atrial fibrillation and who are at a high risk of stroke.

Now Pradaxa can be used to help resolve deep vein thrombosis and pulmonary embolism conditions that may arise from recent hip replacement surgery.

With nearly 300,000 hip replacement surgeries performed each year in the United States, patients who undergo primarily elective hip surgery that do not receive anticoagulant treatment may be at an increased risk of blood clot injuries.

These patients can face up to a 40% to 60% greater risk for deep vein thrombosis, earning Pradaxa a fourth approved purpose from the FDA in the last five years. This approval came after an intensive inquiry of two randomized studies which analyzed phase three trial patients who had undergone total hip replacement surgery.

The first set of data comes from the first Renovate study, which randomly assigned 3494 patients to receive Pradaxa for 28 to 35 days. The results indicate that the patients prescribed Pradaxa faced a deceased risk of venous thromboembolism and deaths from all causes.

In the second Renovate study, 2055 patients were prescribed Pradaxa once again for 28 to 35 days. Lowered rates of blood clot injuries were also found in this study, leading to the FDA to approve Pradaxa for its new use.

Overview of Pradaxa Bleeding Complications

Many are excited for this recent approval, with many experts stating that this addresses a serious medical issue. According to the Thrombosis Research Group at Brigham and Women’s Hospital, a reasonable treatment option can now be available to a large patient population.

Pradaxa was originally approved by the FDA in 2010 to be a new anticoagulant treatment option for patients, and was the first drug to be approved for this purpose since the release of warfarin in the 1954.

While Pradaxa has proven successful in the American market, spurring the release of Xarelto and Eliquis soon after, it has given Boehringer Ingelheim Pharmaceuticals just as much trouble.

Only two years after its release, this drug had allegedly caused over 500 deaths from Pradaxa bleeding incidents. Patients reported instances of uncontrollable internal bleeding, with no Pradaxa antidote available to control bleeding.

Pradaxa bleeding risk complications have led to Boehringer Ingelheim Pharmaceuticals to face numerous product liability claims, and eventually forced the drug company into a major settlement.

The drug company settled more than 4,000 of these Pradaxa bleeding claims in May 2014, paying $650 million to settle the numerous lawsuits.

Boehringer Ingelheim Pharmaceuticals has recently developed a Pradaxa bleeding antidote, Idarucizumab (Praxbind), to reverse the internal bleeding. However, lawsuits alleging Pradaxa complications are still expected for some time to come.