We have previously updated you in July on the safety concern of the use of twice that of placebo, were as follows paroxetine (Seroxat®) in children with major depressive illness and the associated risk of increased emotional liability.

Recent emerging safety information has raised similar concerns of the use of another antidepressant, venlafaxine, in children.

Venlafaxine (Efexor‚ / Efexor XR®, Wyeth), a serotonin and noradrenaline reuptake inhibitor (SNRI), is indicated for the treatment of depression and generalised anxiety disorder in adults. It is not licensed for the treatment of major depressive disorder (MDD) in patients less than 18 years old as safety and effectiveness have not been demonstrated in this population. Recent results from two clinical trials in children and adolescents (6 - 17 years) have failed to demonstrate its efficacy in depressive illness and the results showed an increase in harmful outcomes including hostility, suicidal ideation and self-harm in the venlafaxine group compared to the placebo group.

The MDD trials found that the most common adverse events leading to discontinuation in at least 1% of children and adolescents treated with venlafaxine and occurring at a rate placebo respectively): hostility (2%, <1%) and suicide ideation (2%, 0%). In addition, there were three suicide attempts in the venlafaxine group, compared with none in the placebo group, although there were no deaths in these trials. Other events which occurred more commonly in the venlafaxine group were abdominal pain, loss of appetite and weight loss.