Codeine report released
March 29, 2016
A TGA-COMMISSIONED report
into the efficacy and safety of over-the-
counter codeine combination
medicines has been made public,
with the Advisory Committee on
Medicines Scheduling (ACMS)
providing an update on the upscheduling
of codeine late on Thu.
The Committee met earlier this
month to consider the public
submissions received following its
interim decision last year to upschedule
codeine (PD 01 Oct).
Deliberations included
consideration of alternative options
such as the reduction of pack sizes
and label advisory statements
which were provided for public
comment in Dec (PD 11 Dec).
The new report details an
investigation into the use of OTC
codeine containing combination
analgesics for pain and codeine
based antitussives, undertaken
by Christina Shaheed and Chris
Maher of The George Institute of
Global Health along with Andrew
McLachlan from Sydney University’s
Faculty of Pharmacy.
It consisted of a systematic review
of 14 randomised controlled trials
of the products, with the authors
citing “high quality evidence that
combination codeine medicines
provide clinically important pain
relief in the immediate term”.
However for single dose trials
the effect declines 4-6 hours after
ingestion, while the report also says
codeine-based medicines had been
shown to reduce cough severity, but
not frequency, but “the evidence for
this is every low quality”.
The authors found it hard
to evaluate the incremental
effectiveness of codeine, as
some of the studies comparing
combination medicines did not use
same-drug comparisons, making it
difficult to attribute the findings to
codeine alone.
In terms of safety, “documented
harms associated with codeine
combination misuse included
death, gastric haemorrhage, renal
impairment and life-threatening
biochemical imbalances,” with the
trials evaluated also showing less
serious side effects such as irritated
stomach and tiredness are common
with these medicines.
The Delegate is considering advice
from the ACMS and input from the
public subnmissions, with more
information on the proposal to
reschedule codeine to be published
after Jun 2016.
See www.tga.gov.au for the report.
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