In 1990, case reports described patients who developed intense suicidal ideation during treatment with fluoxetine. In response to this, the manufacturer performed a meta analysis of 17 randomized trials and found no differences in suicidality with placebo.
In 2003 the FDA issued an advisory about suicidality in pediatric patients, this was in response to reports of suicidality in clinical trials. One year later, in 2004, the FDA reexamines the data and issues a warning on increased suicidality in children and adolescents.
In 2005, they studied young adults and decided to issue an advisory on increased suicidality in young adults. Two years later this was included in the current black box warning.
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