Monday, May 14, 2007

FDA proposes new warnings about suicidal thinking and behaviour in young adults on antidepressants.

The FDA is proposing that manufacturers of all antidepressants update the existing black box warning on their products' labelling to include warnings about increased risks of suicidal thinking and behaviour, in young adults aged 18 to 24 during initial treatment (first 1 -2 months). The proposed labelling changes will also include a statement that scientific data did not show this increased risk in adults older than 24, and that adults aged 65 and older taking antidepressants have a decreased risk of suicidality.

The proposed warnings emphasise that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide. The proposed labelling changes apply to the entire category of antidepressants, as available data are not sufficient to exclude any single medication from the increased risk of suicidality.

In 2005, the FDA had started a comprehensive review of 295 individual antidepressant trials that included over 77,000 adult patients with major depressive disorder and other psychiatric disorders, to examine the risk of suicidality in adults prescribed antidepressants. In 2006, its Psychopharmacologic Drugs Advisory Committee agreed that labelling changes were needed to inform health care professionals about the increased risk of suicidality in younger adults using antidepressants. The manufacturers will now have 30 days to submit their revised product labels and revised Medication Guides to the FDA for review.

[Editor's comment: note that the data that form the basis of this warning relate to suicidality - suicidal thoughts and behaviour - but not completed suicide. There have not been enough patients included in controlled trials to get reliable data on completed suicide, however the majority of the relevant data - admittedly all epidemiological, and thus less robust than randomised controlled trials - does not show any increase in completed suicide associated with antidepressive use: in general, there is an inverse relationship overall with a suggestion of an increase in the first few weeks of treatment. A large study that included data from the period before treatment found the month before treatment to be the highest risk.]

The FDA proposals are available here.

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