Even as the maker of Pradaxa has settled thousands of Pradaxa lawsuits, Boehringer Ingelheim Pharmaceuticals has gotten its popular blood thinning medication approved for an additional purpose.

Under U.S. law, the makers of a drug must legally get separate approval for each purpose of their drug. Pradaxa is a blood thinner or anticoagulant, a drug that makes it harder for blood to clot.

Previously, Pradaxa had approval to reduce the risk of dangerous blood clots in patients who had a type of abnormal heartbeat called atrial fibrillation. Yet, despite reported Pradaxa bleeding complications, this approval expands Pradaxa’s use as a preventative anticoagulant treatment during hip surgery.

Pradaxa Approved For Hip Surgery Treatment

The latest approval for Pradaxa is as a “prophylaxis” or preventative treatment during hip surgery. During surgery, blood clots may form in the body and cause conditions such as deep vein thrombosis (blood clots in the legs) or pulmonary embolism (blood clots in the lungs). Sometimes, these blood clots can break loose and migrate through the body until they get stuck in blood vessels, blocking them.

If these blood vessels feed an important tissue, they can cause certain types of heart attack, pulmonary embolism, or stroke, depending on where they get stuck. By making it harder for blood to clot, it is hoped that Pradaxa can reduce the risk of deep vein thrombosis or pulmonary embolism from hip surgery complications.

Pradaxa Bleeding Complications

However, Boehringer Ingelheim Pharmaceuticals have just settled over four-thousand federal Pradaxa lawsuits that argued Pradaxa side effects carried a high risk of irreversible bleeding for which the drug maker failed to disclose.

All anticoagulants carry the risk of causing uncontrollable bleeding. The same biochemical pathways that can cause a dangerous blood clot to form within the body can also stop a person to bleeding to death. This means that if an anticoagulant like Pradaxa works “too well” it can make it impossible for a person to stop bleeding.

As such, even a small injury, even an internal injury, can become life-threatening. This uncontrollable bleeding can take the form of pulmonary bleeding or gastrointestinal bleeding.

Pradaxa Lawsuits

Various Pradaxa lawsuits have further alleged that Pradaxa is less safe than older anticoagulants like Warfarin. This comes down to the issue of a reversal agent. With Warfarin, if a patient experiences uncontrollable bleeding, doctors may effectively shut the drug off with a high dose of vitamin K, allowing the patient to form beneficial clots and stop bleeding.

However, Pradaxa did not have an approved reversal agent until October of 2015, when a Praxbind (idraucizumab) made it through a special fast-tracked FDA approval process. Prior to this, doctors could only use dialysis to try and filter Pradaxa out of the blood or try to overwhelm the drug with high doses of clotting factors. Neither of these techniques was evaluated for efficacy or safety.

Pradaxa lawsuits allege that despite the fact that Pradaxa had no specifically-approved antidote until five years after the drug hit the market, the drugs maker aggressively marketed the drug.

Pradaxa lawsuits typically seek to recoup the cost of emergency medical treatment, compensation for pain and suffering, and compensation for alleged wrongful death in some situations.

Despite the settlement of thousands of Pradaxa lawsuits, a number of Pradaxa lawsuits are continuing to work their way through the legal system through multidistrict litigation known as In Re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation, MDL No. 2385, in the Southern District Court of Illinois.