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Systematic review with meta-analysis.
Submissions to the US Food and Drug Administration (FDA).
Study selection and analysis:
All submitted data on placebo-controlled randomised controlled trials (RCTs) of antidepressants in children were included. Only adverse events that occurred during the double blind treatment period, or within one day of its completion were included. Further data searches for potentially suicide related adverse events were requested from drug companies responsible for 23 of the RCTs. Individual patient data on all potentially suicide related adverse events were provided by drug companies. Narrative summaries of each potentially suicide-related adverse event were reviewed by independent blinded assessors who were experts in paediatric suicidality. Events were categorised as suicide attempt, preparation for impending suicidal behaviour, suicidal …
For correspondence: Thomas Laughren MD, Division of Neuropharmacological Drug Products, HFD-120, 5600 Fishers Lane, Rockville, MD 20857 USA;
Sources of funding: not stated.