This isn't the first country to experience some stumbling blocks with Pradaxa use as the drug has gained momentum—in August Boehringer Ingelheim got the nod from European authorities to sell the drug as a stroke-prevention treatment in atrial fibrillation patients, following European approval to prevent blood clots in patients who've had joint replacement surgery and an earlier stroke prevention approval in the United States, with estimates that Pradaxa will reach sales of  $1.3 billion a year on stroke-prevention alone. But that August approval in Europe was followed a few weeks later by Japanese regulators asking Boehringer Ingelheim to notify physicians about potentially deadly bleeding in some Pradaxa patients, according to a story from Reuters.

 

In fact, Japanese regulators maintained that physicians not only needed to be warned about the bleeding risks of the drug—marketed as Prazaxa in Japan—but also that no remedy exists to counteract bleeding once it begins—unlike with warfarin, for which vitamin K can quickly be administered if bleeding ensues.

 

Another stumbling block for Pradaxa was the decision by the United Kingdom's National Institute for Health and Clinical Excellence (NICE) on Aug. 17 to ask Boehringer Ingelheim for more information on the drug because NICE wasn't convinced Pradaxa was cost-effective, at least not using the data Boehringer had provided at that point. NICE felt that perhaps Boehringer had overestimated the costs of monitoring patients on warfarin, thus overstating the cost-effectiveness of Pradaxa, which reportedly has virtually no need for monitoring, making it easier for patients to take.