Nov 2 The risk of serious bleeding among new
users of Pradaxa, a blood-clot preventer made by Germany's
Boehringer Ingelheim, appeared to be no higher than in patients
on the widely used standard blood thinner warfarin, U.S.
The announcement Friday by the U.S. Food and Drug
Administration may allay some safety concerns about Pradaxa, a
pill developed by the privately held drugmaker Boehringer, to
prevent strokes among patients with an irregular heartbeat known
as atrial fibrillation.
The regulator's findings were based on an assessment of
insurance claims and other data.
Over the past year, the FDA has been analyzing reports of
serious bleeding among patients prescribed Pradaxa, including
gastrointestinal bleeding and bleeding in the brain.
The agency said on Friday a comparable risk of serious
bleeding for Pradaxa and warfarin was suggested by its review of
insurance claims and by analyzing electronic healthcare data
from multiple other sources.
The FDA said it was also planning other assessments of
Pradaxa's bleeding risks.
The medicine competes with Xarelto, a stroke-prevention pill
for atrial fibrillation patients developed by Johnson & Johnson
and Bayer AG.
A similar pill being developed by Bristol-Myers Squibb
and Pfizer Inc, Eliquis, is awaiting U.S.
approval and is deemed by many Wall Street analysts to be the
most impressive of a new generation of oral drugs to replace