Edition 1 - StateWED 16 JUN 2004, Page 003
This drug was
given to thousands of Australian children to combat depression.
Instead it is blamed for putting them on... SUICIDE WATCH
A DRUG given to more than 2000 children in Australia
has been found to trigger suicide attempts, a pharmaceutical giant
A series of studies published by
GlaxoSmithKline show the anti-depressant Aropax poses a danger to those
More than 23,700 prescriptions of the drug were written
for Australian children last year, despite it being banned in
Britain, and America advising against its use. An estimated 100,000
Australian children suffer depression.
The warning follows nine
studies which showed children under 18 who took Aropax developed increased
rates of suicidal tendency, extreme hostility and even worse
The Daily Telegraph has learned that although Aropax is not
approved for children in Australia, doctors have still been
But parents are urged not to take their children
off the medication immediately without seeking medical
Among the thousands of prescriptions, 420 were to
children aged under 9 and another 93 for children under 4, normally
to treat anxiety, autism and developmental disorders.
drug safety watchdog, the Therapeutic
Continued Page 4
Goods Administration, began a review of Aropax use in
children and has now called for a warning label to be put on the
A TGA spokeswoman added it had never approved the use of
the drug for children, but also had no power to stop doctors
Dr Louise Newman, chair of the faculty of child
and adolescent psychiatry at the Royal Australian and New Zealand
College of Psychiatrists, confirmed the information available on Aropax was
But she defended its use in children, saying many
antibiotic and other drugs not approved for use in children were
given to them.
``These drugs can be effective,'' she said, adding
that it would be a ``bigger issue'' if childhood depression was not
Australia has one of the highest suicide rates in the
Western world, rating second only to motor accidents as the largest
killer of the young.
One study reported by the Australian
Department of Health and Ageing found 4.3 per cent of Year 11 boys
and 6.4 per cent of girls of the same age suffer from depression --
the primary cause of suicide.
In total, more than 220,000
prescriptions of anti-depressants including Prozac, Zoloft and
Efexor were written for children and teenagers in 2003 despite none
of them being officially approved.
Only Prozac has been proved to
be effective in treating depression in children.
yesterday confirmed Aropax had not been approved
in Australia for use in patients under 18.
GlaxoSmithKline's policy not to promote off-label use of any of our
Aropax * After years of
pressure, GlaxoSmithKline has revealed Aropax can cause children to
* Doctors have been advised against prescribing
it to teens until its effects are reviewed
* Australia's drug
safety watchdog has called for warning labels on the bottles
is banned in the UK
Q What are the
concerns about Aropax?
A The US Food and
Drug Administration says the US version of Aropax should not be used for
the treatment of major depressive disorder in children and
adolescents while it reviews reports of an increased risk of
suicidal thinking and suicide attempts by users under the age of 18.
Glaxo-SmithKline, the company which makes Aropax in Australia, has
revealed its own research raises serious concerns about the
Q Should children using Aropax stop taking it
A It is very important that children and adolescents
not stop taking Aropax suddenly, as there is a
risk of after effects. Carers of children and adolescents currently
taking the drug should consult their doctor. If their doctor advises
that Aropax should be stopped, this
should be done gradually to minimise the risk of after effects. If
severe affect effects occur by stopping its use, it may be necessary
to start taking Aropax again or increase the
dose before subsequently decreasing the dose more
Q Is Aropax approved for the
treatment of children and adolescents?
A In Australia the
Therapeutic Goods Administration, has not approved the drug for use
in children and adolescents. Some doctors are nonetheless
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