50 deaths tied to anti-stroke pill
Source: Agencies |
November 3, 2011, Thursday
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Print Edition
Print Edition
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 yesterday, heightening health regulators' attention.
"Fifty cases is a reasonable order of magnitude that has emerged so far," a company spokesman said yesterday, 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 markets this year. Britain's health care cost-effectiveness watchdog on Tuesday recommended the use of Pradaxa. 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.
Germany-based 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.
The pill is one of many new anti-blood-clotting pills expected to replace the decades-old and difficult-to-handle warfarin pill. Rival drugs include Xarelto from Bayer and Johnson & Johnson, Eliquis from Bristol-Myers Squibb and Pfizer, and Daiichi Sankyo's Lixiana.
"Fifty cases is a reasonable order of magnitude that has emerged so far," a company spokesman said yesterday, 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 markets this year. Britain's health care cost-effectiveness watchdog on Tuesday recommended the use of Pradaxa. 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.
Germany-based 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.
The pill is one of many new anti-blood-clotting pills expected to replace the decades-old and difficult-to-handle warfarin pill. Rival drugs include Xarelto from Bayer and Johnson & Johnson, Eliquis from Bristol-Myers Squibb and Pfizer, and Daiichi Sankyo's Lixiana.
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