About-face on drug danger advice

Toran Henry and his mother Maria Bradshaw were not told of the risks of overdosing on Fluoxetine. Photo / Supplied

A health board has withdrawn advice about the risks of giving antidepressants to adolescents and children after the medicines regulator Medsafe questioned the accuracy of the information.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, 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 the generic Prozac drug 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The Waitemata board has since withdrawn the information.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.