The first courtroom trials involving Pradaxa liability are scheduled to start in September. The blood-thinning drug has been linked to serious bleeding injuries and death.
Aside from being “the most complained about drug in America” according to several news reports as well as the FDA, Pradaxa is facing potentially stiff competition from two new anti-coagulants: Bayer’s Xarelto and Eliquis, manufactured by Pfizer and Bristol-Meyer-Squibb.
It’s not helping Pradaxa manufacturer Boerhringer-Ingelheim that it is facing increasing legal action over its flagship product – which, unlike Coumadin, has no antidote and was allegedly poorly tested prior to its FDA approval and subsequent introduction to the market. In addition to the Pradaxa lawsuits and increased FDA scrutiny. Now, clinical trials as well as an analysis of adverse events reports are strongly suggestiong that Eliquis is a safer, more effective alternative.
It should come as no surprise that BI and Bayer are crying “foul.” They may have reason: according to an article on the website Fierce Pharma, results for Eliquis, the most recent entrant into the anticoagulant marketplace, are based on a very small sample – and the drug itself has not been around for very long, compared to its competitors.
In the meantime, BI is likely to continue to lose customers as lawsuits against the company continue to mount. As of mid-March, the number of cases against BI is up by 4% over the previous month, while at the same time, research published in the journal Gastroenterology indicate that a patient is 55% more likely to bleed to death while on Pradaxa. At the same time, the Institute for Safe Medication Practices reports that Pradaxa patients are five times more likely to suffer a fatal hemorrhage. BI’s own records report that an average of two patients a day are dying as a result of taking Pradaxa, with hundreds more being admitted to emergency rooms every month.