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The Daily Telegraph
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
By SUE DUNLEVY

A DRUG given to more than 2000 children in Australia has been found to trigger suicide attempts, a pharmaceutical giant admitted yesterday.
A series of studies published by GlaxoSmithKline show the anti-depressant Aropax poses a danger to those under 18.
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 depression.
The Daily Telegraph has learned that although Aropax is not approved for children in Australia, doctors have still been prescribing it.
But parents are urged not to take their children off the medication immediately without seeking medical advice.
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.
National drug safety watchdog, the Therapeutic
Continued Page 4
From Page 3
Goods Administration, began a review of Aropax use in children and has now called for a warning label to be put on the bottles.
A TGA spokeswoman added it had never approved the use of the drug for children, but also had no power to stop doctors prescribing it.
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 inadequate.
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 treated.
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.
GlaxoSmithKline yesterday confirmed Aropax had not been approved in Australia for use in patients under 18.
``It is GlaxoSmithKline's policy not to promote off-label use of any of our medicines.''

Aropax * After years of pressure, GlaxoSmithKline has revealed Aropax can cause children to attempt suicide
* 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
* It is banned in the UK

Overseas concerns
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 drug.

Q Should children using Aropax stop taking it immediately?
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 gradually.

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 prescribing it.

Illus:  Photo
Section:  LOCAL

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