Links between anti-depressants and suicide?

Bradshaw's different tack was to apply her research skills and knowledge of the law - she graduated from Auckland University with an MBA in 2007 and worked as a court registrar in Dunedin and for Internal Affairs. The result is Lessons Learned From The Death Of Toran Tiavare Henry, a 161-page, footnoted document with appendices that reads like a bit like a thesis, which she released yesterday. The report spares no one, naming staff at Takapuna Grammar, Marinoto and elsewhere involved in Toran's care. It also lays out details about Toran's death that would normally be reserved for the coroner's hearing and "identifies deficiencies in my performance of my parental responsibilities which may have contributed to his death".

Her number one failure is that she "did not take all possible action to prevent Toran taking Prozac, which I believed was harmful to him". Bradshaw says while she monitored side-effects very closely, she should have ensured Toran did not overdose on the drug, or mix it with alcohol. Her son was among the thousands of New Zealanders prescribed anti-depressants. Pharmac figures show that in 2007/08, 1.2 million prescriptions were issued to adults, 14,733 for 6 to 18 year olds, and 72 for children aged five and under.

Bradshaw wishes she knew then what she now knows about the side effects of fluoxetine. She is particularly concerned that the psychiatrists she dealt with and the information she was given downplayed the risks.

No one told her, for example, that Prozac-type medications are not approved for use in New Zealand for people aged under 18 for the treatment of depression.

What that means, says medicines regulator Medsafe, is that informed consent must be obtained from the patient or parent prior to Prozac-type antidepressant treatment in children or adolescents. Informed consent also means properly outlining all the risks and side effects associated with the drugs - for example that overdoses can be fatal, or cause potentially fatal effects such as cardiac arrest.

What's important too, is that parents are told about the differences between approved and unapproved or "off-label" uses.

Information pamphlets given to Toran and his mother advocated a number of off-label uses including for autism, attention deficit hyperactivity disorder, and bed-wetting.

Medsafe was concerned the difference was not made clear. "Parents/carers should be informed when medicines are used outside of their approved use in order for them to make an informed decision as to whether the potential benefits of treatment outweigh the risks," said Medsafe senior pharmacovigilance adviser Susan Kenyon in a letter to Bradshaw.

In Toran's case, says Bradshaw, the prescription was off-label on two counts - Toran being under 18 and that he had not been clearly diagnosed with major depressive disorder, an authorised use of the drug for adults.

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

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

Asked about another document, Antidepressant Medication: A Guide for Carers, produced by the Werry Centre for Child and Adolescent Mental Health at Auckland University, Aydon confirmed it, too, had been withdrawn.

She could not say what new information was being given to patients.

While the Werry Centre document was still available online on Friday, Werry Centre director of workforce development Sue Treanor said it was an old document and had been withdrawn.

"We are having a problem with Google cache which our web company is trying to rectify, meaning there are ghosts of withdrawn documents still in the system," she said.

Medsafe and the DHB were concerned about statements in the Werry Centre document that Prozac-type medications were "relatively safe in overdose, especially compared with older medications" and that the drugs had been "intensively studied over the last 25 years with no evidence of any long term problems arising from their use".

Medsafe group manager Dr Stewart Jessamine said there were still discrepancies with the current New Zealand data sheets.

"Vetting publications such as this does not fall under Medsafe's remit, so we will be informing the Medical Council, given this is a clinical practice issue rather than a product safety one," he said.

Jessamine said Medsafe was not responsible for material written and provided to patients by individual medical practitioners. Responsibility rested with the authors. So what exactly should parents know about the use of antidepressants for children?

Medsafe datasheets on the various drugs are a good place to start, although the language used may be difficult to understand.

But from Bradshaw's point of view, the warnings could have been more obvious.

In the United States Prozac-type drugs come with a "black box" label warning for something called activation syndrome, which the Marinoto external review panel agreed it was possible Toran had developed.

On the Medsafe datasheet under the heading "Warning: Clinical Worsening and Suicide Risk" it is described as including symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity and mania.

When Bradshaw raised concerns that Toran may have developed activation syndrome, she says she was told by a Marinoto doctor to "stop reading research and trust his professional judgment".

She wishes she had followed her instincts, done more research and sought a second opinion.