The study allays the concerns that led the FDA to issue a ‘black box warning’ on the drug in 2004, and led many clinicians to question the EMA’s approval of the drug for treatment of children and teenagers in the same year.
An analysis of data from 41 trials with more than 9,000 patients showed that the antidepressants fluoxetine and venlafaxine neither increased nor decreased suicidal thoughts and behaviours in children.
Lead trial author Robert Gibbons, Professor of Medicine, Health Studies and Psychiatry at the University of Chicago Medicine, said the new findings should reassure doctors about the safety of prescribing these medications.
The FDA’s black box warning on fluoxetine was prompted by retrospective adverse event data from 25 clinical trials (based primarily on self-reporting), which revealed a small but significant increase in suicidal thoughts and behaviour in patients aged below 25.
The new analysis was based largely on a major National Institute of Mental Health study of fluoxetine and venlafaxine, including weekly screening of patients for depression and suicidal thoughts, and comparing the effects of drug and placebo.
Trials of fluoxetine in children showed a reduction in depressive symptoms relative to placebo, but no significant change in suicide risk.
Gibbons commented that the lack of a direct impact on suicidal thoughts suggests that “the effects of antidepressants in kids and adults are not really the same, since we don’t see anything but beneficial effects of antidepressants in adults. In kids, we don’t see a harmful effect, but we do see a disassociation between the beneficial effects on depression and the potential beneficial effect on suicide.”
Previous FDA research found that the ‘black box warning’ on fluoxetine had significantly reduced antidepressant prescriptions to both children and adults, and this correlated with an increase in suicide rates.