Antidepressants ‘need suicide risk on warning label’


Warning labels like those on cigarette packs should feature on antidepressant packets in Australia, cautioning about the risk of suicide, parents and experts argue.

"Prominent warnings of severe risks should appear on the outside packaging of all medicines," academic Martin Whitely said.

"Doctors should be compelled to advise parents and patients of the risk and that they are prescribing the drugs "off label" for an unapproved use."


In the US, fluoxetine (Prozac) is among a number of medications that carries a suicide warning on the inside of its packet. Picture: Alamy
In the US, fluoxetine (Prozac) is among a number of medications that carries a suicide warning on the inside of its packet. Picture: Alamy


Mr Whitely, who has been arguing for the labels for more than a decade, said the current system of inserting caution notes in antidepressant packets was flawed.

Aside from many of the warnings going unread, he said not everybody gets the inserts, as it is not mandatory for chemists to put them it in.

Leading child psychiatrist Adelaide University Professor Jon Jureidini said "medicine packaging should alert patients to any severe risks identified for that medicine."

"Doctors should always advise parents and patients whenever medicines are being used 'off label'," he said.

The US medical regulator, the Food and Drug Administration (FDA), insisted upon labels, in bold type, on the inside of packets - called black box notifications - in 2004.

Its caution note reads: "Antidepressants increase the risk compared to placebo of suicidal thinking and behaviour (suicidality) in children, adolescents and young adults in short term studies of major depressive disorder (MDD) and other psychiatric disorders."



The FDA warning appears on medications including citalopram (Celexa), fluvoxamine (Luvox), paroxetine (Paxil), fluoxetine (Prozac), sertraline (Zoloft), venlafaxine (Effexor), mirtazapine (Remeron), nefazodone (Serzone), and bupropion (Wellbutrin).

They were put in place after the British regulator the Medicines and Healthcare products Regulatory Agency (MHRA), found in 2003 clinical trials had not demonstrated antidepressants were efficacious in young people and, with the exception of fluoxetine (Prozac), should not be used to treat adolescents with major depressive disorders.



The MHRA expert working group noticed an increased risk of suicidal behaviours among adolescent patients being treated with SSRI antidepressants, prompting the FDA to do its own investigation.

Product information sheets inside medication packets in the UK, Canada and Europe for all antidepressants contain some version of a warning statement regarding the risk of clinical worsening and suicidality.

If you need help with a mental health issue contact Lifeline 131114 or Kids Helpline 1800 55 1800



Originally published as Antidepressants 'need suicide risk on warning label'