FRANKFURT, Nov. 2 Boehringer Ingelheim's new stroke prevention pill Pradaxa has been linked to about 50 deaths from bleeding across the world since its market launch, the company said on Wednesday, heightening health regulators' attention.
"Fifty cases is a reasonable order of magnitude that has emerged so far," a company spokesman told Reuters on Wednesday, adding that the number of deaths was within expectations from the clinical study that led to its market approval.
Pradaxa, an anti-clotting pill, won regulatory clearance in the United States for stroke prevention in October 2010, followed by other important markets this year.
Britain's healthcare cost-effectiveness watchdog NICE on Tuesday recommended the use of Pradaxa, after getting additional information on the medicine from the company.
Like other anti-blood-clotting treatments, Pradaxa's benefit of cutting the rate of fatal or debilitating strokes comes at the risk of internal bleeding, which can also cost lives.
Boehringer said this week it agreed with European regulators that patients about to take Pradaxa should have their kidneys checked, further dimming the safety profile of the first in a promising new class of medicines.
Any malfunction of the kidneys, which gradually filter Pradaxa's active ingredient out of the blood stream, could lead to overdosing and increase the risk of dangerous bleeding.
Japanese regulators told Boehringer in August to issue a strong warning to doctors of potentially deadly bleeding as a result of use of Pradaxa.
The pill is one of a number of new anti-blood-clotting pills expected to replace the decades-old and difficult-to-handle warfarin pill. Analysts estimate the total annual market for such oral drugs at as much as $20 billion.
Rival anti-clotting drugs include Xarelto from Bayer and Johnson & Johnson , Eliquis from Bristol-Myers Squibb and Pfizer , and Daiichi Sankyo's Lixiana.
All four have the drawback that there is no antidote to stop internal bleeding from an overdose.
By contrast, the effect of established drug warfarin is cancelled out if patients eat vitamin K-containing vegetables such as spinach or broccoli and that also makes it difficult to get the dosage of warfarin right.