Boehringer Ingelheim, manufacturer of one of the newer anticoagulant drugs made to compete with warfarin, offered an initial Pradaxa settlement of $650 million in 2014.

This Pradaxa settlement was announced to end over 4,000 state and federal legal claims that had been brought against them by patients and/or family members that suffered uncontrolled internal bleeding without antidote and were severely injured or died.

A year and five months after the announcement of the initial Pradaxa settlement, in October 2015, the U.S. Food and Drug Administration (FDA) approved an antidote for Pradaxa through an expedited process.

This antidote is called Praxbind but generically is known as idarucizumab. It allows emergency room physicians and personnel to bring uncontrolled bleeding back under control by reversing the bood thinning effects of Pradaxa.

Praxbind Comes a Little Late for Those that Suffered

The initial Pradaxa settlement of $650 million came as litigation against the Boehringer Ingelheim Company was piling up. The new anticoagulant drug was approved by the FDA in 2010 and, in its first year on the market, was the subject of an excessive number of adverse medical event reports to the drug oversight agency.

Allegedly, over 500 people lost their lives this first year because of uncontrolled bleeding. Thousands more patients were critically injured by the same blood-thinning action that couldn’t be reversed if needed. Pradaxa was sold for five years without a reversal agent.

The Promotion of Pradaxa

Pradaxa is one of the newer anticoagulant drugs that was promoted by its makers as superior to the ‘tried and true’ warfarin. Warfarin requires more frequent dosing than once per day and needs blood-monitoring as well as some dietary changes during therapy.

According to Boehringer Ingelheim, Pradaxa required only once a day dosing and presented no need for blood monitoring or avoidance of different foods. The promotion failed to mention that, while warfarin’s action could be reversed by a rapid infusion of Vitamin K, there was no option when it came to Pradaxa.

Solutions that were employed in the absence of an antidote was kidney dialysis, drug removal (skipping one to two doses), and undergoing transfusions. Sometimes these actions were effective, but sometimes, they took too long to make a difference and patients died.

The Mechanism of Action

Pradaxa, like the other new anticoagulant drugs, works by inhibiting thrombin, a human blood clotting factor. It is prescribed for people that are prone to produce blood clots in the lower extremities which can then travel to the heart and lung region causing respiratory and or cardiac arrest.

The conditions for which it prescribed specifically are deep vein thrombosis (DVT), pulmonary embolism (PE) and strokes related to atrial fibrillation, a condition which makes the heart beat ineffectively at times.

Pradaxa is also prescribed for patients undergoing total hip or knee replacements to prevent the creation of blood clots afterwards. While Praxbind now exists as a viable antidote for the anticoagulant, many question the safety of Pradaxa and whether it should still be trusted at all.

It has been attributed to serious cases of gastrointestinal, kidney, and brain bleeding. While it is not recommended to ever go off of a medication without the counsel of your physician, it is important to know that there are better alternatives.