Staff Writer

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.

Mental health helplines

If you or someone you know is feeling distressed and/or having suicidal thoughts, see your doctor, phone one of these helplines or click on the links below for online web chat counselling or support. Call 000 if life is in danger.

Lifeline (24 hours) 13 11 14
Kids Helpline (for young people aged 5 to 25 years) 1800 55 1800
Beyond Blue Support Service (24 hours) 1300 22 4636
MensLine Australia (24 hours) 1300 78 99 78
SANE Helpline – mental illness information, support and referral 1800 187 263
Suicide Call Back Service (24 hours) – free counselling support 1300 659 467

Last Reviewed: 18/09/2015

Reproduced with kind permission from Australian Doctor


References

Le Noury J, et. al. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. http://www.bmj.com/content/351/bmj.h4320