Paroxetine suicide warning for adolescents

17 September 2015

Staff Writer

paroxetine suicide warning for adolescents

Has paroxetine's true suicide risk been hidden for years?

There are renewed concerns over the safety of paroxetine the antidepressant in adolescents following the reanalysis of the original trial data by Australian researchers.

Paroxetine goes under many brand names in Australia, including Aropax, Extine and Roxet as well as others containing the word "paroxetine".

Researchers re-examined the original clinical trial data for paroxetine, and highlighted major flaws, including incorrect statistical models and failure to include all adverse events.

The reanalysis has come to the conclusion that paroxetine (20-40mg) is linked to suicidal or self-harming behaviours in 12-18-year-olds.

It also found that the antidepressant is no better at relieving symptoms of major depression in adolescents than placebo (dummy pills), according to the new study published in the BMJ.

The findings come 14 years after paroxetine was proclaimed "generally well-tolerated and effective for major depression in adolescents" following the publication of a randomised, double-blind, placebo-controlled trial.

This original study, involving 275 adolescents with major depression, was known as Study 329 and was funded by the drug's manufacturer GlaxoSmithKline.

However, the original trial documents were only recently made publicly available by GSK in response to public pressure, making the latest reanalysis possible.

GSK Australia's spokeswoman noted that the company had included clear warnings of the risk of suicide on paroxetine for more than a decade.

In 2014, more than half a million scripts for paroxetine were written for Australian patients with depression.

National Helplines
If you or someone you know is depressed and/or having suicidal thoughts, see your doctor, or phone one of these helplines.
Lifeline (24 hours)13 11 14
Kids Helpline (under 18 years of age)1800 55 1800
Just Ask - rural mental health information1300 13 11 14
Mensline Australia (24 hours)1300 78 99 78
SANE Helpline - mental illness information, support and referral1800 18 SANE (7263)
Suicide Call Back Service (24 hours) - free telephone counselling support1300 659 467


Le Noury J, et. al. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence.
Australian Doctor