DPP products to stay on ARTG
June 18, 2012
THE Administration Appeals
Tribunal has over-ridden the Health
Minister and the Therapeutic
Goods Administration’s decision to
cancel the registration of Di-Gesic
and Doloxene.
Di-gesic and Doloxene were both
automatically registered on the
ARTG when the Act commenced in
1991, with the former containing
32.5mg of DPP hydrochloride and
325mg of paracetamol, and the
latter containing 100mg of DPP.
The cancellation process began in
November last year, when the
delegate of the Secretary of the
Department of Health and Ageing
gave notice of a proposal to cancel
the registration of all products
containing dextropropoxyphene
(DPP) from the ARTG from 01
March 2012, due to new evidence
which showed the medicines’
unacceptable safety profile.
The evidence was found by the
TGA in a review which concluded
that DPP affected the electrical
activity of the heart, increasing the
risk of serious arrhythmias; and
that it can be/has been/and will be
used for the purpose of deliberate
suicide; and that it had a high risk
for accidental overdose.
Following the cancellation
announcement Aspen, marketer of
Di-Gesic and Doloxene in Australia,
asked the Health Minister to
reconsider the decision, and on 23
January the Minister affirmed the
original decision to remove both
products from the ARTG.
Aspen then sought review by the
Administrative Appeals Tribunal.
The Tribunal granted a stay to
enable Aspen to continue supply of
both products, while the review
was in process, after the company
undertook to add significant safety
warnings to the product
information and consumer
medicine information.
In looking at the case, the
Tribunal concluded that there was
not enough “robust evidence” to
support the case that DPP increases
the risk of serious arrhythmias; and
that in terms of the drug’s suicide
risk, that “it is not appropriate to
refuse registration approval for a
preparation simply on the basis
that it may be used deliberately for
the purposes of self-harm”.
“Many therapeutic preparations
share that quality,” the Tribunal
said.
In relation to the drugs’
accidental overdose risk profile, the
Tribunal found that whilst there is a
relatively small variation between
the dose that is described as
therapeutic and the amount which
is sufficient to create a risk of
serious adverse harm and even the
risk of fatality, Aspen has met ADEC
review safety-related conditions
such as the use of blister packaging,
decreased pack sizes and changes
to the Product Information to
include a stronger statement
regarding the use of DPP with
alcohol and other drugs.
As a result of its findings, the
Tribunal overturned the Minister’s
decision that the registration of the
products should be cancelled, and
as such Di-Gesic and Doloxene will
remain on the ARTG.
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