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Paroxetine 'causes harm in adolescents', researchers claim

Paroxetine in not effective in adolescents with major depression and actually causes harm, a reanalysis of a major study has revealed.

The trial - Study 329, funded by GlaxoSmithKline - was first published in 2001, with the results reported as showing paroextine was safe and effective for adolescents.

Now a team has reanalysed the study, this time using previously confidential trial documents, and found neither paroxetine nor another drug tested in the trial was more effective than placebo, whereas there was a clinically significant increase in harms, including suicidal ideation and behaviour.

The authors concluded: ‘Neither paroxetine nor high dose imipramine showed efficacy for major depression in adolescents, and there was an increase in harms with both drugs.’

GPs were advised against prescribing SSRIs to young people in 2003 by the MHRA after concerns they may be linked to increased suicide-related events.

NICE recommends children and young people with moderate to severe depression should be referred to Child and Adolescent Mental Health Services (CAMHS) after which they should only be prescribed antidepressants after assessment and diagnosis by a specialist child and adolescent psychiatrist.

GP experts in mental health said the new analysis suggested GPs should be cautious with SSRIs in general and avoid paroxetine altogether.

Professor Carolyn Chew-Graham said the ‘study supports the need for GPs to be cautious with any SSRI, and to avoid paroxetine’.

She said: ‘Guidelines already suggest that GPs need to carefully consider a decision to prescribe any SSRI antidepressant in an adolescent patient with depression, and consider alternatives where possible.’

Professor Chew-Graham added that this should include referral to CAMHS but that ‘many GPs would report long waiting times for appointments and default to prescribing because of this’.

Professor Andre Tylee, emeritus professor of primary care mental health at the Institute of Psychiatry, Kings College London, said he study re-analysis was ‘helpful to confirm the current advice’.

The re-analysis is the first piece of work to be published in the BMJ as part of an initiative called RIAT – Restoring Invisible and Abandoned Trials.

BMJ 2015; available online 16 September

Readers' comments (5)

  • Vinci Ho

    So it took 14 years to finally prove a drug company was wrong in the first place! Of course, the excuse is only time and experience will tell. But does that mean the company should refund all the money spent on Paroxetine in these youngsters , back to NHS???
    Depression in adolescence is complex, I think the only antidepressant safe enough to be used if necessary is fluoxetine (an BMJ article a few years ago)

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  • SSRIs simply don't work. Note the bit about getting previously unreleased data! Its a disgrace ! There is no evidence that serotonin plays a role in depression!

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  • I wouldn't be surprised if it is eventually proven that all SSRI cause harm over all.

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  • All SSRI's have very severe life threatening adverse effects.
    They do not have proven efficacy in depressive illness (all levels of intensity) and are vastly over-prescibed. The growing awareness of the importance of the entire, unpublished, pharmaceutical industry sponsored and controlled; i.e. "data censored" trial data base will continue to cause increasing discomfort to conscientious medical practitioners.
    Until the reality of lack of efficacy and severe toxicity is more widely appreciated in primary and secondary care, the ability to immediately diagnose acute SSRI induced AKATHISIA is paramount to avoid catastrophic patient harms.
    SSRI induced AKATHISIA is an acute Medical Emergency, potentially a prodrome of imminent Serotonin Syndrome.
    There is an urgent need to consider referral to the Medical Assessment Unit where restoration of fluid balance, resuscitation and transfer to I.T.U are immediately available.
    How many severe AKATHISIA presentations lead to unnecessary and inappropriate psychiatric admissions with addition, often enforcement of more toxic psychotropics? - - plus of course, even more inappropriate detention, when the AKATHISIC patient requests "no more medication".
    Even though they are now extremely ill with prescription medication toxicity, they are also likely to be the only person who recognises the cause.

    Time for Study 329 to be redacted.

    T.R.Moss. F.R.C.G.P. Retired Physician.

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  • With apologies for typo.

    Of course - "it is time to RETRACT STUDY 329.

    T.R.M.

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