Cough and cold changes
July 6, 2012
NEW labelling for cough and cold
medicines will soon appear in
pharmacies nationwide, according
to the Australian Self Medication
Industry (ASMI).
The changes are the result of a
Therapeutic Goods Administration
review undertaken in April 2009
which looked at the active
ingredients used in children’s cough
and cold medicines.
The review looked at antitussives
for acute cough in children
(dextromethorphan, codeine,
pholcodine and dihydrocodine);
expectorants for acute cough in
children; antihistamine
monotherapy for the common cold
and acute cough in children;
antihistamine-decongestant
combinations for the common cold
and acute cough in children; and
nasal decongestants for the
common cold.
The review found that because
there is strong demand for these
medicines for children, this is
sometimes interpreted as evidence
for efficacy.
“The reviewers do not agree with
this interpretation, but there is no
evidence to refute or support this
idea”, the review said.
As a result of the review’s findings
the TGA declared that “In light of
the current lack of evidence of
efficacy and the historical profile of
adverse drug reactions (ADRs) in
Australia and overseas, it is likely
that the risks associated with the
use of cough and cold preparations
in children outweigh the likely
benefits for children below the age
of 6 years”.
The TGA also found that “there is
currently a lack of evidence of
efficacy for cough and cold medicines
in children aged 6 to 12 years of age
and the historical profile of ADRs
indicates that there are potential
risks involved in use of these
medicines in that age group also”.
As a result, the TGA now requires
that cough and cold products
transition their labelling to indicate
that: the products are not to be
used for children under six years of
age; and that for children between
six and 12 years of age, the advice
of a pharmacist or doctor should
initially be sought before giving the
products.
The new labels, according to
ASMI, will no longer contain
instructions for children under 6
years of age, and may now carry
instructions to only use the product
for children between the ages of 6
and 12 on the advice of a doctor or
pharmacist.
“It is worth remembering that
there has been no change in the
products themselves, no change to
where you can buy them and no
change to the adult dosing,” said
ASMI Regulatory and Scientific
Affairs Director, Steve Scarff.
“In the absence of modern
efficacy data, the TGA took a
precautionary approach
and decided to limit the age groups
for which there would be labelled
dosing instructions,” he added.
Meanwhile, in terms of stock,
pharmacists can continue to sell
their existing stock, as there is no
time restriction as to when it has to
be run off shelves.
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