Researchers have recently found that the antidepressant fluoxetine did not increase or decrease suicidal behaviour in children, compared to children who were on placebos.
This finding is contrary to concerns arising in 2004 that feared antidepressant drugs increased suicidal thoughts in children and youth, and prompted an FDA “black box warning.” The earlier warning was based on retrospective data from 25 clinical trials of antidepressants, including fluoxetine (marketed as Prozac or Sarafem) which showed a small, but significant increase in suicidality in children and youth.
This new analysis of clinical trial data was based on 41 trials and more than 9,000 patients and included weekly screening of each trial subject for depression and suicidal thoughts. For adult and geriatric populations, fluoxetine and venlafaxine reduced depression and reduced suicide risk. Children who were taking fluoxetine (the only antidepressant approved for paediatric use in the USA) experienced reduced depression and no significant increase or decrease in suicide risk.
The analysis and findings are published in the February 6, 2012 online version in the journal of Archives of General Psychiatry. The abstract can be found at www.archpsyc.ama-assn.org.