TGA pain killer controversy
November 24, 2011
THE Therapeutic Goods
Administration’s decision to cancel
all pain killers containing
dextropropoxyphene (Capadex,
Di-Gesic, Doloxene and Paradex)
from the Australian Register of
Therapeutic Goods from 01 March
2012, has sparked arguments
across the industry, with Aspen
Australia rejecting the decision as
“flawed”.
The cancellation, which was
announced yesterday, is based on
a TGA review of “available
evidence” which revealed that
dextropropoxyphene affects the
electrical activity of the heart,
increasing the risk of serious
arrhythmias.
As such, the risk profile of the
quartet was deemed to outweigh
their pain relief benefit.
The result of the ARTG removal,
means that from 01 March 2012
Di-Gesic, Capadex, Paradex and
Doloxene will no longer be
supplied in Australia.
The TGA advised patients taking
Capadex, Di-Gesic, Doloxene or
Paradex regularly for chronic pain
to consult their GP about
alternative medicines, as sudden
stoppage may result in withdrawal
symptoms; whilst short term users
have been advised to swap to
alternative pain drugs immediately.
Health professionals were also
advised to plan with patients the
change to an appropriate
alternative method of pain relief at
the earliest opportunity.
Opponents to the cancellation
have however labelled the move as
“wrong”, with Aspen Australia
saying that the TGA relied on a
flawed study with “questionable”
data in making its decision.
According to Aspen, the study
which the TGA used to draw its
conclusion, was done in the US, and
involved a single non-representative
sample of six patients.
“Contrary to the TGA’s conclusions,
Aspen remains of the view that the
experience of use of the products
by patients in Australia over the
past 40 years demonstrates that
Aspen’s DPP-containing products
are both safe and efficacious,” said
a statement from Aspen.
“Indeed, Aspen estimates that
over the past 40 years, close to 2
billion tablets/capsules of DPPcontaining
products have been sold
in Australia alone,” the statement
said, adding that ADRAC reports
show an “enviable record of
adverse events”, and that DPP
products are still used in 39
countries with “no major problems”.
The company did however note
that whilst DPP products remain in
use in the UK and Europe, there
are tighter controls for usage and
availability in these regions.
Aspen has announced it will
pursue the TGA appeal process in
relation to the matter, as well as
“other avenues of appeal which
may be open to it”.
Aspen also said it has identified
and is currently in the process of
obtaining access to additional data
and evidence which is relevant to
the cancellation and which it believes
will prove the safety of the products.
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