FRANKFURT Aug 18 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
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
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.
LACK OF ANTIDOTE
The ministry also told the company to make Japanese doctors
aware there was no medicine capable of reversing its
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
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)