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Antidepressants and suicide symptoms: compelling new insights from the FDA’s analysis of individual patient level data
  1. Corrado Barbui1,
  2. Andrea Cipriani1,
  3. John R Geddes2
  1. 1Department of Medicine and Public Health, Section of Psychiatry and Clinical Psychology, University of Verona, Verona, Italy
  2. 2Department of Psychiatry, Warneford Hospital, University of Oxford, UK
  1. Dr M Henderson, Division of Psychological Medicine, Institute of Psychiatry, King’s College London, 3rd Floor, Weston Education Centre, 10 Cutcombe Road, London SE5 9RJ, UK; m.henderson{at}iop.kcl.ac.uk

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In May 2007 the Food and Drug Administration (FDA) ordered that all antidepressant drugs carry an expanded black-box warning incorporating information about an increased risk of suicidal symptoms in young adults aged 18–24 years. The new warning was based on the results of a FDA meta-analysis that included 372 placebo-controlled antidepressant trials and nearly 100 000 patients.1 On the basis of this analysis the relationship between antidepressant drug treatment and the incidence of reported suicidal behaviour in clinical trials was strongly related to age: the risk associated with drug treatment relative to placebo was found to be elevated in subjects under age 25, neutral in subjects aged 25–64 (reduced if suicidal behaviour and ideation are considered together), and reduced in subjects aged 65 and older.

Paradoxically, these data have been interpreted as reinforcing and consolidating two opposing positions. On one side, it has been argued that antidepressant drugs do not kill people, the real killer is untreated depression with its high lifetime risk of suicide.2 On the opposite side of the divide it is argued that the well documented risks associated with antidepressant drugs largely prevail over uncertain benefits.3

Both these positions seem very far from the everyday experience of treating depression. Under ordinary circumstances doctors have always considered suicide symptoms as useful and pragmatic measures of clinical outcome. If, after a reasonable period of time, suicidal thoughts or plans occur, persist, or get worse, then treatment is considered insufficient. If we apply this pragmatic approach to the FDA Report, a high degree of coherence between its main findings and the literature …

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