4000 kids under 10 on mood drugs

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UNPUBLISHED figures show that nearly 4000 children under the age of 10 were prescribed anti-depressants last financial year, including 553 children under five and 48 babies.

by The Australian - Monday, 8 December 2008

The commonwealth Department of Health statistics give an alarming, although most likely conservative, age-by-age breakdown of the national use of anti-depressants.

Leading pediatricians and psychiatrists can offer no reason why infants would be given the drugs.

Depression expert Gordon Parker said the numbers were "beyond comprehension" and urged the federal Government to ask doctors responsible for supplying scripts for young children to justify their actions.

Professor Parker, the executive director of the Black Dog Institute, said: "At first pass it is beyond comprehension that more than 500 Australian children - aged one to five years - have received an anti-depressant drug.

"When the particular drugs are considered, the risk of significant side effects - let alone their efficacy - is of key concern. It strikes me that there would be wisdom in having the doctors justify such prescriptions to determine whether there are any justifiable reasons for such surprising data."

The figures are based on Pharmaceutical Benefits Schedule data that covers only people who received a subsidised prescription. Most anti-depressants are sold privately.

Asked what circumstances might lead to a baby being treated with an anti-depressant drug, the spokesman for the pediatric division of the Royal Australian College of Physicians, John Wray said: "None that come to mind. The college would like to know who is prescribing these drugs to such young children and why."

Parliamentary Secretary for Health and Ageing Jan McLucas said the Government would be "very concerned if anti-depressant medications were being inappropriately prescribed and dispensed, particularly to children".

The Therapeutic Goods Administration said in a statement last night that it was powerless to regulate the use of off-label medicines as it was not illegal for doctors to prescribe drugs for non-approved indications. But it said there might be medical practice and medico-legal implications associated with prescribing a medication outside its approved indications.

The Adverse Drug Reactions Advisory Committee warns doctors against prescribing any of the SSRI anti-depressant drugs to children under 18 - aside from two that are approved for obsessive compulsive disorder in children aged over six years - and points out that the drug companies themselves advise against their use for any condition.

There are numerous examples in the Health Department figures that show doctors are ignoring the warnings.

The anti-depressant drug Venlafaxine, which is marketed here as Effexor by Wyeth Australia, carries a clear statement that reads: "Do not give Effexor XR to children or adolescents under 18 years of age. The safety and effectiveness of Effexor XR in this age group have not been established."

Despite this, 3347 children and teenagers were prescribed the drug last financial year. Eight of those were babies, 19 were aged two and three and another 15 were five years old. A spokeswoman for Wyeth said the drug was not indicated for use in children and adolescents below 18 years of age, and it had never recommended its use in this population. No anti-depressant is approved in Australia for the treatment of depression in children and adolescents.

Two SSRI anti-depressants have Therapeutic Goods Administration approval to treat children as young as six years for Obsessive Compulsive Disorder; other, older-style anti-depressants can be prescribed by doctors to treat bed-wetting. But even allowing for these conditions, Royal Australian College of Psychiatrists spokesman Peter Jenkins said the figures were mysterious and worrying.

The Health Department figures were obtained by the Citizens Commission on Human Rights, a Church of Scientology-backed lobby group opposed to anti-depressant therapy.

The most comprehensive research into SSRI anti-depressants and their use in children and adolescents in 2004 led to drug manufacturers around the world being forced to include a warning in their product information, stating the drugs could increase the risk of suicidal thoughts and behaviour in children. This followed the results of an extensive analysis of clinical trial data by the US Food and Drug Administration.

According to the Health Department figures, the most commonly prescribed anti-depressant for children and adolescents aged under 18 years is Prozac, with 7833 given the drug in the past year, including 863 children aged under 10.

The Australian revealed recently that the TGA was investigating the adverse effects of SSRIs, the most widely prescribed group of anti-depressants that includes the well-known brands Prozac and Zoloft.