SSRIs take another hit in the medical literature

by | 20th Dec 2006 | News

Two articles published in the European journal Psychotherapy and Psychosomatics will add fuel to the still highly flammable debate over the relationship between new-wave antidepressants and suicide.

Two articles published in the European journal Psychotherapy and Psychosomatics will add fuel to the still highly flammable debate over the relationship between new-wave antidepressants and suicide.

In a secondary analysis of an open, multicentre 12-week trial of fluoxetine 20mg (Eli Lilly’s Prozac) in US outpatients with non-psychotic major depressive episodes, researchers from Lilly and a number of US medical institutions found that 59 of 414 participants (14.3%) without suicidal ideation at baseline reported SI on at least one post-baseline visit.

The researchers also used Cox regression models to examine adverse effects and other clinical features associated with the emergence of suicidiality. These analyses revealed that emergence of activation and increased severity of depression were independently associated with the emergence of SI. Treatment response and remission were significantly less likely among trial subjects who developed SI.

In the same edition of Psychotherapy and Psychosomatics, Professor David Cohen of the Department of Child and Adolescent Psychiatry at the Université Pierre et Marie Curie in Paris reviewed the recent literature addressing the use of selective serotonin re-uptake inhibitors, such as fluoxetine, in child and adolescent depression.

The review took in 10 publications evaluating the efficacy of four SSRIs – fluoxetine, paroxetine (Paxil/Seroxat, GlaxoSmithKline), sertraline (Zoloft/Lustral, Pfizer) and citalopram (Cipramil/Celexa, Lundbeck/Forest Laboratories) – in a total of 2,046 patients. Professor Cohen also noted that another six trials (total: 1,234 patients) were not reported by industry due to lack of efficacy or problematic side-effects, including suicidal behaviour.

SSRIs should remain second-line

Meta-analyses of these sources did not turn up any data supporting the use of SSRIs in these settings, with the exception of fluoxetine, Professor Cohen said. He concluded that an SSRI prescription remained a second-line option in severe and resistant forms of youth depression. However, only specialists well trained in child and adolescent psychiatry should prescribe SSRIs to these populations.

Last week an advisory panel to the Food and Drug Administration voted six to two in favour of expanding the ‘black box’ warnings about increased risk of suicide on US antidepressant labelling from the present population of children and adolescents to anyone under the age of 25 years.

The labelling change, which many doctors and psychiatrists have condemned as counterproductive, was prompted by an FDA review of data from 372 trials with antidepressants. These suggested that the risk of suicidal thinking or suicide attempts was 62% higher in adults under 25 taking antidepressants, compared with those on placebo.

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