About-face on drug danger advice—(The New Zealand Herald)

SSRI Ed note: Teen on Prozac dies by suicide, mum Maria Bradshaw successfully lobbies to stop New Zealand regulator issuing misinformation. Psychiatrist John Werry objects.
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The New Zealand Herald

4:00AM Friday Mar 20, 2009

By Chris Barton

Antidepressants and kids: A mother’s fight for fully informed consent

A health board has withdrawn advice about the risks of giving antidepressants to adolescents and children after the medicines regulator Medsafe questioned the accuracy of the information.

The Waitemata District Health Board told patients of Marinoto North’s adolescent mental health unit that Prozac-type drugs “are safe in over-dosage so cannot be used by patients to commit suicide”.

But after the death a year ago of Marinoto patient Toran Henry, 17, using generic Prozac drug fluoxetine, Medsafe has written to the health board’s chief executive and chief pharmacist detailing its concerns about the advice.

It was particularly concerned that the advice did not say it was possible to overdose with three commonly used drugs, including fluoxetine.

“An overdose can be fatal, or cause effects such as cardiac arrest which are potentially fatal,” said Medsafe senior adviser Susan Kenyon.

Medsafe was also concerned that information about side effects was not comprehensive, and that one of the pamphlets advocated unapproved uses of antidepressants including for autism, attention deficit hyperactivity disorder, and bed wetting.

The Waitemata board has since withdrawn the information.

Figures from the drug funding agency Pharmac show that for the year to June 2008, 1.2 million adult prescriptions for antidepressants were issued. For children and adolescents aged 6 to 18, the figure was 14,733, and children 5 and under received 72 prescriptions. There were 263,000 prescriptions for fluoxetine at a cost of $1.2 million.

The health board advice was brought to the attention of Medsafe in January by Toran’s mother, Maria Bradshaw. She says her son was prescribed fluoxetine without proper informed consent. Mrs Bradshaw has since learned that Toran often took more than his prescribed dose of the drug because it enabled him to become intoxicated from alcohol more quickly.

She said she and her son were not told of the overdosage risk or, as outlined in the Medasfe datasheet on the drug, that “the safety and efficacy of fluoxetine for the treatment of children and adolescents less than 18 years of age has not been established.”

In a letter to Mrs Bradshaw, Mrs Kenyon wrote: “Medsafe considers that patients and parents/carers should be informed when medicines are used outside their approved use in order for them to make a more informed decision as to whether the potential benefits of treatment outweigh the risks.”

The information for the Waitemata advice came from the Werry Centre for Child and Adolescent Mental Health at Auckland University.

“Now that Medsafe has raised concerns about the accuracy of this document we will ensure that it is no longer handed out to patients,” Waitemata health board communications manager Lydia Aydon told the Herald.

She was referring to a 2004 document, Antidepressants for Children and Youth, by child and adolescent psychiatrist professor John Werry.

Werry Centre director of workforce development Sue Treanor said another document, Antidepressant Medication: A Guide for Carers, had also been removed from the centre’s website.

Professor Werry said last night Medsafe had not contacted him, “but rather has chosen to go behind my back and write to another party”.

Professor Werry said he was not involved with the centre, and added: “The view that Medsafe expresses on the risks associated with the use of SSRI (Prozac type antidepressants) are not those of the child and adolescent psychiatrists in New Zealand, and are inconsistent with the research data.

“This had been pointed out to them but they have refused to change their position.”

Medsafe’s statement that the risks of prescribing Prozac-type antidepressants outweighed the benefits “constitutes a serious threat to the mental health of adolescents.”