Pradaxa safety info update
February 11, 2013
THE Therapeutic Goods
Administration has issued an
update on the use of Pradaxa
(dabitragan), detailing the findings
of a review last Aug which
“reinforced the importance of
appropriate patient selection” for
the safe use of the medication.
Pradaxa is an oral coagulant used
for the prevention of clots and
emboli after hip or knee
replacements, to prevent stroke in
people with non-valvular atrial
fibrillation.
The TGA says there appears to be
a trend towards a higher incidence
of major bleeds in patients aged 75
years or over taking dabigatran
150mg twice daily compared to
warfarin, and cited a range of
factors known to increase the risk
of bleeding.
The review of the medication
followed an increase in adverse
events reports associated with the
use of Pradaxa, after approved
indications were extended to
include the prevention of stroke
and systemic embolisum in patients
with non-valvular AF and at least
one risk factor for stroke.
The drug’s manufacturer,
Boehringer Ingelheim, said the TGA
review outcomes had echoed those
of other reviews by the FDA and
the European Medicines Agency.
“Boehringer Ingelheim is pleased
that the TGA has issued this update
which is in line with those from
overseas regulatory agencies,” said
the firm’s md Wes Cook.
He said the core prescribing
information had not changed, with
the company supporting “the TGA’s
reinforcement of key elements of
the Pradaxa prescribing
information”.
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