No TGA appeal on Di-Gesic
October 11, 2013
The Therapeutic Goods
Administration has confirmed
that it will not be appealing the
decision of the Administrative
Appeals Tribunal which allowed
the continued sale of medications
containing dextropropoxyphene in
Australia (PD 09 Apr, 16 Sep).
In an update yesterday the TGA
said that any appeal would have
been limited to questions of law,
rather than the scientific or medical
merits of the decision.
It would have also delayed the
implementation of the conditions
imposed by the AAT designed to
ensure the safe use of Di-Gesic and
Doloxene.
“The TGA believes safeguards
that the AAT found were necessary
to ensure the safe use of these
products through the imposition of
these conditions should be in place
as soon as possible,” the TGA said.
The special conditions on the
supply of dextropropoxyphene
came into effect yesterday,
meaning that sponsor Aspen
Australia now has until 24 Oct to
lodge an application to vary the
Product Information documents for
Di-Gesic and Doloxene.
Then within 30 days of the PI
changes being approved by the TGA
the sponsor is required to write to
doctors, dentists and pharmacies to
provide further information about
the conditions.
The company will also advise
when to start using the new
Prescriber Confirmation Form,
which must be correctly completed
by doctors or dentists before
pharmacists are permitted to
dispense the products.
The new arrangements will also
require pharmacists to provide a
Patient Information Sheet.
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