Boehringer Ingelheim Pharmaceuticals Inc. announced it submitted a supplemental new drug application for Pradaxa to be used to prevent deep venous thrombosis (DVT) and pulmonary embolism (PE) among patients who have undergone primary elective total hip replacement surgery.

If this Pradaxa supplemental drug application is approved, it will become the fourth approved use of Pradaxa. The supplemental new drug application is based on the results of two randomized, double-blind Phase III trials, comparing enoxaparin and Pradaxa’s ability to prevent venous thromboembolism (VTE) and death in patients required to undergo hip replacement surgery.

According to Boehringer representatives:

“Total hip replacement is a common procedure, and preventive anticoagulant treatment is recommended because of the potential for DVT and PE, which can be life-threatening for some patients. The acceptance of this sNDA is another step toward expanding the therapeutic uses for Pradaxa to improve patient outcomes in this population.”

The first test for the supplemental new drug application showed that patients taking Pradaxa had a lower VTE and cause of death than those on enoxaparin. While these results are promising and indicate that this new higher dose of Pradaxa is effective in reducing the likelihood of clots, all drugs still have risks. Pradaxa has been known to cause uncontrollable bleeding events in some patients.

Pradaxa Internal Bleeding Complications

The FDA originally approved Pradaxa in 2010 as an anticoagulant treatment for individuals needing blood thinners and seeking an alternative to the more traditional blood-thinning medication known as Warfarin (coumadin).

However, after just three months on the pharmaceutical market, the FDA received over 307 reports of severe Pradaxa side effects leading to patient injury, including internal bleeding, gastrointestinal bleeding, and other Pradaxa complications. Additionally, within the first year, there were over 260 reported Pradaxa deaths that were allegedly caused by gastrointestinal bleeding, internal bleeding, hemorrhage, and stroke drug-induced side effects.

Many Pradaxa lawsuits allege the reason there are so many incidences of Pradaxa bleeding complications is because the anticoagulant drug has no known reversal agent, unlike Warfarin which can be stopped by a dose of vitamin K.

Until the body flushes out the Pradaxa dose by dialysis, a patient must undergo multiple blood transfusions and even risk death before the uncontrollable bleeding side effects subside.

In light of these reports, the FDA issued a December 2011 drug and safety warning  to inform consumers and doctors of the uncontrollable bleeding risks associated with the use of Pradaxa. Following this announcement, many consumers have chosen to file Pradaxa lawsuit and Pradaxa class action lawsuits, alleging that the manufacturers of Pradaxa misled consumers concerning the safety of using Pradaxa and neglecting to inform them of the internal bleeding side effects.