Dextropropoxyphene win
April 9, 2013
Di-Gesic and Doloxene
will continue to be available
to Australian pain sufferers,
after a decision last Fri by the
Administrative Appeals Tribunal
(AAT) that medications containing
dextropopoxyphene should remain
on the Australian Register of
Therapeutic Goods.
It’s the culmination of a longrunning
saga initiated more than
12 months ago (PD 24 Nov 2011)
when the Therapeutic Goods
Administration decided to cancel
the registration of Capadex,
Doloxene, Paradex and Di-Gesic
effective from 01 Mar 2012.
At the time the decision was
based on a TGA review of “available
evidence” which showed the
compound can affect the electrical
activity of the heart, potentially
increasing the risk of arrhythmia.
Aspen Australia, which supplies
Di-Gesic and Doloxene, claimed the
TGA had relied on a flawed study of
just six patients, describing the data
as “questionable”.
Early last year Aspen applied for
a stay of the suspension from the
ARTG (PD 17 Feb 2012), and then
in Jun the Administrative Appeals
Tribunal issued a decision which
referred the matter back to the
Therapeutic Goods Administration.
The TGA once again decided to
suspend the medications, with
Aspen subsequently launching a
further AAT case (PD 13 Sep).
Aspen said as part of that appeal
that there would be patients left
without satisfactory pain relief if
the medications were removed
from the market.
A final hearing was set down for
Feb this year (PD 09 Nov 12) after
the TGA confirmed that it had
considered various proposals put
forward by the sponsors of the
medicines which would allow them
to stay on the ARTG.
However the TGA said it “was
not satisfied that the proposals
would address the safety issues
identified”.
In this latest decision the Tribunal
has now decided that both
Di-Gesic and Doloxene should
remain on the ARTG, subject to the
implementation of conditions to
promote the safe use of the drugs.
“The AAT’s decision was made
after considering the evidence of
scientific and medical experts put
forward by both the Therapeutic
Goods Administration and Aspen
over the course of a week during
2012, and a further hearing in
February 2013,” according to
a statement issued by Aspen
yesterday afternoon.
Aspen said it would provide
further details of the conditions
that will be implemented, in further
communications to pharmacists.
“Doctors may continue
to prescribe both products
after carefully considering
the indications, warnings and
contraindications in the Product
Information and Consumer
Medicines Information for these
products,” the company said.
Di-Gesic is currently available at
community pharmacies while info
on the availability of Doloxene,
which is currently out of stock, will
be provided shortly.
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