Medsafe questions accuracy of DHB's advice

Waitemata District Health Board has withdrawn advice about the risks of giving antidepressants to adolescents and children.

Its decision came after medicines regulator Medsafe questioned the accuracy of the information.

Patients of Marinoto North's adolescent mental health unit had been told by the DHB that Prozac-type drugs were "safe in over-dosage so cannot be used by patients to commit suicide".

However a year ago Marinoto patient Toran Henry, 17, died using the generic Prozac drug fluoxetine, and now Medsafe has written to the board with its concerns about the advice.

The Waitemata board has since withdrawn the information, the New Zealand Herald reported today.

"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 said.

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

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

The regulator also had concerns 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 health board advice was brought to the attention of Medsafe in January by Toran Henry's mother, Maria Bradshaw, who said her son was prescribed fluoxetine without proper informed consent.

She said she and her son were not told of the overdosage risk or, as outlined in the Medsafe 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".