Careful monitoring required for paroxetine (seroxat) and suicide risk in young adults with depression


The debate about antidepressant use and suicide in young people rages on. A new meta-analysis of placebo-controlled paroxetine trials has been published in the Journal of Clinical Psychiatry by a research team at GlaxoSmithKline (the company who make the drug also known as Aropax, Paxil and Seroxat) in Pennsylvania.

This kind of drug company conducted meta-analysis always raises alarm bells, but it’s interesting to read on when the study findings are not wholly positive, as they are not in this case.

The meta-analysis uses data from the GlaxoSmithKline paroxetine clinical trial database, including all double-blind, randomized, placebo-controlled, parallel-group studies of paroxetine therapy in adults (14,911 patients in total from 61 trials).

The study found:

  • no significant differences between paroxetine and placebo for overall suicidality (suicidal behavior or ideation: n/n = 83/8,958 [0.93%] vs n/n = 65/5,953 [1.09%], respectively; OR = 0.9 [95% CI, 0.7-1.3]; P = .649)
  • no difference for suicidal behavior specifically (n/n = 50/8,958 [0.56%] vs n/n = 40/5,953 [0.67%], respectively; OR = 1.2 [95% CI, 0.8-1.9]; P = .483).
  • a greater incidence of suicidal behavior occurred in paroxetine-treated patients with depression than in placebo-treated patients (n/n = 11/3,455 [0.32%] vs n/n = 1/1,978 [0.05%], respectively; OR = 6.7 [95% CI, 1.1-149.4]; P = .058).
  • a higher incidence of suicidal behavior occurred in paroxetine-treated versus placebo-treated adults aged 18 to 24 years (n/n = 17/776 [2.19%] vs n/n = 5/542 [0.92%], respectively; OR = 2.4 [95% CI, 0.9-7.3]).
  • no increase in suicidality was observed in older people.

The authors concluded:

Across all disorders, overall suicidality incidence was similar between paroxetine and placebo. However, a higher frequency of suicidal behavior occurred with paroxetine in major depressive disorder, which was largely explained by the higher incidence in young adults.

These data support the efficacy of paroxetine therapy; however, they also highlight the need for careful monitoring of suicidality during antidepressant therapy, particularly in younger adults.

Carpenter DJ, Fong R, Kraus JE, Davies JT, Moore C, Thase ME. Meta-analysis of efficacy and treatment-emergent suicidality in adults by psychiatric indication and age subgroup following initiation of paroxetine therapy: a complete set of randomized placebo-controlled trials. J Clin Psychiatry. 2011 Feb 22. [Epub ahead of print] [PubMed abstract].

If you need help

If you need help and support now and you live in the UK or the Republic of Ireland, please call the Samaritans on 116 123.

If you live elsewhere, we recommend finding a local Crisis Centre on the IASP website.

We also highly recommend that you visit the Connecting with People: Staying Safe resource.

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Andre Tomlin

André Tomlin is an Information Scientist with 20 years experience working in evidence-based healthcare. He's worked in the NHS, for Oxford University and since 2002 as Managing Director of Minervation Ltd, a consultancy company who do clever digital stuff for charities, universities and the public sector. Most recently André has been the driving force behind the Mental Elf and the National Elf Service; an innovative digital platform that helps professionals keep up to date with simple, clear and engaging summaries of evidence-based research. André is a Trustee at the Centre for Mental Health and an Honorary Research Fellow at University College London Division of Psychiatry. He lives in Bristol, surrounded by dogs, elflings and lots of woodland!

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