Unpublished figures show that nearly 4,000 children under the age of 10 were prescribed antidepressants last year, including 553 children under five and 48 babies, even though no antidepressant is approved in Australia for the treatment of depression in children and adolescents,The Australian reports.
"At first pass, it is beyond comprehension that more than 500 Australian children - aged one to five years - have received an antidepressant drug," Gordon Parker, executive director of the Black Dog Institute, a non-profit devoted to education about depression and bipolar disorder, tells the paper. "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 subsidized prescription, according to the paper, which notes that most antidepressants are sold privately. A spokesman for the pediatric division of the Royal Australian College of Physicians was unable to explain the prescribing patterns: "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 tells the paper that the government would be "very concerned if antidepressant medications were being inappropriately prescribed and dispensed, particularly to children." And the government's Therapeutic Goods Administration issued a statement saying it was powerless to regulate the use of off-label med, but maintained there might be medical practice and medico-legal implications associated with prescribing a drug beyond approved indications.
The Adverse Drug Reactions Advisory Committee warns doctors against prescribing any of the SSRI antidepressant 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 drugmakers themselves advise against their use for any condition.
There are numerous examples in the Health Department figures that show doctors are ignoring the warnings, according to the paper.
Wyeth's Effexor carries this statement: "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." Yet, 3,347 children and teenagers were prescribed the drug last financial year. Eight were babies, 19 were aged two and three and another 15 were five years old. A Wyeth spokeswoman tells the paper 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.
Two SSRI antidepressants have Therapeutic Goods Administration approval to treat children as young as six years for Obsessive Compulsive Disorder; and other, older antidepressants can be prescribed by doctors to treat bedwetting. But even allowing for these conditions, Royal Australian College of Psychiatrists spokesman Peter Jenkins tells the Australian 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 drugmakers being forced to include a warning in product labeling, 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 FDA in the US.
According to the Health Department figures, the most commonly prescribed antidepressant 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.
Source: The Australian