Call to restrict pholcodine
June 3, 2014
A RECENT article in the Australian
Prescriber has called for pholcodine
to be re-classified to prescription
only, saying there is good evidence
linking the drug to an increased
risk of anaphylactic reactions to
neuromuscular blocking drugs.
‘Anaphylaxis and anaesthesia -
can treating a cough kill?’, written
by Tweed Hospital Anaesthetic
Allergy Clinic director and
consultant anaesthetist Helen Crilly
and Anaesthetic Allergy Clinic Royal
North Shore Hospital director and
consultant anaesthetist Michael
Rose, said anaphylaxis during
surgery had been estimated in
approximately one in 10,000 cases.
“Neuromuscular blocking drugs
are responsible for approximately
60% of intraoperative anaphylaxis.”
The article said while the reported
rate of anaphylaxis caused by
neuromuscular blocking drugs was
“much higher” in Australia, the
true incidence was unknown due
to reporting being voluntary and
multiple drugs being administered
at the time of anaesthesia but it
was likely under-reported, it said.
The article said following the
withdrawal of pholcodine from the
Norwegian market by the supplier,
the rate of anaphylactic reactions
to neuromuscular blocking drugs in
Norway had “significantly reduced”.
The European Medicines
Agency found that the evidence
of a link between pholcodine and
anaphylaxis was circumstantial,
calling for further data to clarify
this.
“While it may be argued that
there is insufficient proof to ban
pholcodine, its lack of efficacy and
a strong suspicion of danger should
be regarded as sufficient for it to be
withdrawn.
“If it is not possible to withdraw
pholcodine from the market,
we propose a re-classification to
‘prescription only’.”
The Department of Health
said the Therapeutic Goods
Administration had reviewed this
issue and concluded there was
insufficient evidence to support the
association at this stage.
“There is no current consideration
of the scheduling of pholcodeine
being conducted.
“A decision to include a substance
in a particular Schedule must take
into account the balance between
the public’s legitimate need to
access these substances and the
need to protect the community
from potential health risks.”
To read the article, CLICK HERE.
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