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Row erupts over infant cough medicine laws -

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Row erupts over infant cough medicine laws

The World Today - Thursday, 10 April , 2008 12:34:00

Reporter: Annie Guest

ASHLEY HALL: Pharmacists and Australia's drug watchdog are at loggerheads over restrictions on
common cough and cold medicines.

Some of the more common sedating antihistamine drugs will soon only be available on prescription
for children under the age of two.

The Therapeutic Goods Administration says some parents have used the drugs to sedate infants,
causing hallucinations, insomnia and agitation.

The drug watchdog also says there's no evidence the drugs have any benefit for children under two.

But pharmacists claim some parents are already threatening to give infants medicines designed for
older children.

Annie Guest reports.

ANNIE GUEST: Pharmacists say angry parents have already confronted them over the drug watchdog's

KOS SCLAVOS: Since news has broken yesterday, pharmacists are receiving messages from angry parents
in particular in terms of their ability to access these products.

ANNIE GUEST: The National President of the Pharmacy Guild, Kos Sclavos says the Therapeutic Goods
Administration is being irresponsible.

Medicine commonly given to children with coughs and colds contain sedating antihistamines.

The TGA has ruled that from September, they can only be given on prescription to children under the
age of two.

It will affect 15 drugs, including those in the Demazin and Dimetapp ranges.

Drug Manufacturers and doctors are yet to respond.

Pharmacists have already decided the ban is unnecessary.

KOS SCLAVOS: Every medicine has a risk and that is why the pharmacist gives guidance, whether it is
a prescription, a complimentary medicine or an over-the-counter medicine like these products. At
the end of the day, the risks on these products was not at a level where the feedback and the
evidence on the ground was that it was of a large concern to the Australian public.

ANNIE GUEST: More seriously, Kos Sclavos warns it will result in further drug misuse.

KOS SCLAVOS: The most concerning feedback I have is that parents are saying well that's OK, I'll
just get the older children's drinks and change the dose down for my young child. That is quite
dangerous so it is sending certainly the wrong message.

ANNIE GUEST: The TGA's National Manager is Dr Rohan Hammett.

ROHAN HAMMETT: I think the role of pharmacists providing advice to patients as they get
over-the-counter medicines is to make it clear to them that it is no longer safe, nor appropriate,
to use these medicines in children under the age of two, and pharmacists and doctors need to be
providing that advice.

ANNIE GUEST: Dr Hammett says the TGA can't be certain how many Australian infants have had problems
after being given the drugs.

He says deaths reported in the United States were not linked to the exact drugs being restricted by
the TGA.

ROHAN HAMMETT: In Australia we have only a handful of reports of adverse drug reactions associated
with these medicines. Some of those relate to potential accidental over-dosage of the baby.

ANNIE GUEST: If the medicines are considered unsafe enough to be prescription-only from September,
why is it safe to wait until then?

ROHAN HAMMETT: The September 1st start date applies to the fact that they will be prescription-only
from that date and that is the usual legal process. We are talking about parallel processes. There
is a process that runs through the National Drugs and Poisons Scheduling Committee. Quite
separately to that, the TGA has determined that it is no longer appropriate to use these medicines
in children under the age of two.

Now that is not because there is an imminent risk of danger. It is, instead, because it is no
longer appropriate to use these medicines because they don't produce benefits that outweigh the
risks of using them in young babies.

ANNIE GUEST: Is there any sign that these drugs do any good for children under two?

ROHAN HAMMETT: There is no evidence that these drugs produce any benefits for babies under the age
of two.

ASHLEY HALL: Dr Rohan Hammett from the Therapeutic Goods Administration speaking with Annie Guest.