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This revised report updates the original document published on 9 December 2020, responding to feedback received about the initial publication. The TGA's safety investigation was conducted in response to a review article by Whitely, Raven, and Jureidini, in July 2020 that identified a decade-long pattern of increasing antidepressant use and increasing rate of suicide in young Australians. The aims of this safety investigation were to assess:
- The strength of the current evidence for a causal association between prescribing of antidepressants and rates of youth suicide;
- The international regulatory landscape with respect to use of antidepressants in children and adolescents and risk minimisation;
- The current role of antidepressants in clinical practice for the treatment of psychiatric and developmental disorders in young people in Australia; and
- Whether the current risk minimisation measures in place in Australia are adequate.