Authorities eye warnings on youth anti-depressants

By SIMON COLLINS

New Zealand authorities will meet in a fortnight to consider requiring warning labels on anti-depressants for young people, after a US Food and Drug Administration move against the drugs .

The FDA said it "generally supports the recommendations" of an expert panel who voted 15-8 last week in favour of "black-box" statements on all anti-depressants, including Prozac, warning that they may cause a higher risk of suicidal behaviour among young people.

The panel's vote followed two days of emotional hearings in Washington, where tearful families testified that their children had committed suicide after taking anti-depressants.

An FDA analysis found that only 2 to 3 per cent of young people treated with anti-depressants might be at higher risk of suicidal behaviour. But this, combined with evidence that the drugs may have little positive value in young people, was considered enough to impose the warnings.

A "black-box" warning is the strongest type used for prescription drugs and means that the warning must be used in all advertisements as well as on instruction leaflets in the drugs' packaging.

Pharmac subsidised 13,004 prescriptions of anti-depressants to people aged 18 and under in New Zealand in the 12 months to June last year, equivalent to 3249 young people taking the drugs for a year.

Just over three-quarters of these were for so-called "new anti-depressants", or Selective Serotonin Re-uptake Inhibitors (SSRIs), including Prozac and its generic form, which is marketed here as Fluox.

The FDA panel recommended black-box warnings on all anti-depressants, including all SSRIs and older drugs known as tricyclics.

New Zealand's Medicines Adverse Reactions Committee (Marc) wrote to doctors in March passing on a British agency's finding that there was evidence for increased suicidal thoughts and behaviour in young people using all major SSRIs except fluoxetine, the chemical that is marketed as Prozac or Fluox.

It advised doctors to seek specialist advice before prescribing anti-depressants to children or adolescents.

The principal technical specialist of the Health Ministry's Medsafe agency, Dr Stewart Jessamine, said last week that Marc would consider the latest FDA statement and other available data when it met in two weeks.

"We recognise that this is a very important issue for parents and children using this medication and take this issue very seriously."

The FDA panel was split on the balance of risks and benefits of anti-depressants for young people.

Wellington's Mental Health Consumers Union manager, Sarah Porter, said anti-depressants had their place but were not appropriate long-term.

"It's not something I would choose for myself, and if it's people I cared about and loved I wouldn't necessarily choose it for them."