TGA warning on Di-Gesic
April 15, 2013
The Therapeutic Goods
Administration has issued an
update on dextropropoxyphene-containing
medicines such as
Di-Gesic and Doloxene, following
the recent Administrative Appeals
Tribunal decision which saw them
remain on the market (PD 07 Apr).
The TGA says that in the ruling
the AAT “recognised the potential
safety risks” associated with the
products, and in particular that the
difference between a therapeutic
amount and a potentially fatal dose
was “smaller than in many other
therapeutic products”.
Without a continuation of the
significant safety warnings in the
CMI and PI for the medicines,
as well as periodic reminders to
doctors and pharmacists about the
risks associated with the use of the
product, “the safety and efficacy
of Di-Gesic and Doloxene would be
unacceptable,” the AAT found.
In accordance with the directions
from the AAT, the TGA will now
negotiate a process with the
sponsor to ensure the safety risks
can be effectively monitored.
“The TGA anticipates that the
conditions will have the effect of
placing significant responsibility
on prescribers and pharmacists
to ensure the new supply
arrangements are met in order to
protect public health”.
The TGA also noted that a number
of countries had withdrawn
approval for dextropropoxyphene
containing products, including the
US, NZ, the UK, the EU, Singapore
and South Africa.
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