FRANKFURT, Aug 18 (Reuters) - Japanese regulators told Boehringer Ingelheim to issue a strong warning to physicians of potentially deadly bleeding as a result of use of its stroke prevention pill Prazaxa, the first in a promising new class of medicines.
The country’s health ministry MHLW said in a so-called Blue Letter earlier this month that between March 14 and Aug. 11, 81 of the almost 64,000 mainly elderly patients taking the Prazaxa pill suffered heavy bleeding, leading to five deaths.
That would be equivalent to about one in 330 patients suffering serious bleeding, mostly in the digestive tract, over a one-year period.
The ministry said in the letter that the unlisted German company needs to tell doctors about these risks and that a lower dose may have to be given to certain patient groups, such as those over 70 or with kidney damage.
A Boehringer spokesman told Reuters on Thursday it was complying with Japanese requests and it was in the company’s interests that the medicine be prescribed strictly within the guidelines.
The pill, called Pradaxa outside Japan, has been on the U.S. market since late last year and is one of three new anti-blood-clotting pills expected to replace the decades-old, and potentially dangerous, stroke preventer warfarin.
Analysts estimate the total annual market for such oral drugs at as much as $20 billion.
The ministry also told the company to make Japanese doctors aware there was no medicine capable of reversing its anti-coagulation effect.
The lack of an antidote could also be a concern for rival anti-clotting drugs, such as Xarelto from Bayer (BAYGn.DE) and Johnson & Johnson , Eliquis from Bristol-Myers Squibb and Pfizer , and Daiichi Sankyo’s Lixiana, as the New England Journal of Medicine pointed out last week.
This is the negative flip side of a major advantage of the new generation of drugs: they do not interact with certain foods like warfarin does.
The effect of warfarin, a so-called Vitamin K inhibitor, is damped if patients eat certain vegetables with that vitamin such as spinach, cauliflower or broccoli. By the same token, bleeding due to warfarin can simply be addressed by giving Vitamin K.
Boehringer earlier this month won European clearance for its stroke prevention pill.
But Britain’s healthcare cost-effectiveness watchdog on Wednesday demanded more information on Boehringer Ingelheim’s anti-clotting pill before deciding whether to recommend it for use on the state-funded National Health Service.
Bayer and development partner J&J in January filed for U.S. and European approval of its Xarelto pill, based on the active ingredient rivaroxaban, for stroke prevention. (Reporting by Ludwig Burger Frank Siebelt, with Timothy Kelly in Tokyo; Editing by David Holmes)