January 1, 1970 · FLEMING | NOLEN | JEZ, L.L.P.
Pradaxa (generic name dibigatron) is an anti-clotting drug invented and manufactured by Boehringer Ingelheim Pharmaceuticals. Boehringer Ingelheim is a German company with offices around the world, including the United States. Pradaxa was approved by the FDA in October 2010 to combat atrial fibrillation, in other words, to prevent strokes by preventing blood clots.
Undoubtedly, strokes are a significant medical problem in the United States; strokes are the third leading cause of death per year. Pradaxa was thought to be a game changing drug in stroke prevention as the first major alternative in several decades to the commonly prescribed drug, called Warfarin.
Indeed, only two years ago there was great excitement about Pradaxa, as many experts and physicians thought it would be significantly more effective than Warfarin. Pradaxa has a mechanism of action that is quicker to act than Warfarin, and it is easier to calculate the correct dosage of Pradaxa. Pradaxa is typically prescribed at 150 mg twice daily, and is thought to be effective within hours of the first dosage. And importantly, Pradaxa’s side effect profile was originally thought to be generally lower than Warfarin. Unfortunately, the honeymoon period for Pradaxa is over – the drug merely trades one problem for another in many patients.
Boehringer Ingelheim’s emerging problem is while patients who take Pradaxa might have a lesser risk of having a stroke, these patients also incur a significant risk of internal bleeding. Specifically, the drug acts as a powerful blood thinner to prevent clotting, but Pradaxa is now believed to cause certain patients to hemorrhage blood. This bleeding can lead to extreme damage in the body, including causing heart attacks and death.
In November 2011, Boehringer Ingelheim confirmed at least 260 fatal bleeding events in patients taking Pradaxa. The company was forced by the FDA to update the Pradaxa warning label & medication guide early in 2012 to disclose risks of bleeding after damaging reports emerged from Japan and Australia. Alarmingly, just weeks ago the Journal of Neurosurgery published an article raising more questions and concerns about Pradaxa; the most significant position was that the bleeding side effects and damage caused by Pradaxa areirreversible.
Unsurprisingly, as is its routine practice, the FDA looks to have taken the mantra of “approve now, ask questions & make changes later” with regards to approving and testing Pradaxa for the market in the United States. Boehringer Ingelheim decided react and change Pradaxa’s warning label only after people have begun to die and/or suffer damaging health effects. The company is now facing the threat of widespread potential litigation, as the first Pradaxa lawsuits were filed several weeks ago. Pradaxa was once thought to be a medical breakthrough in stroke prevention, but instead, the drug now has a substantial possibility of acting as the catalyst for an extraordinary full-blown health crisis and costly litigation for Boehringer Ingelheim.