Regulatory warnings regarding the risk of suicidal thoughts and behaviours appear to be associated with reductions in the number of antidepressant medication prescriptions among children and adolescents, according to a new report.
In December 2003, the UK Committee on Safety of Medicines declared the risk-benefit profile of all selective serotonin reuptake inhibitor (SSRI) antidepressants (as well as venlafaxine hydrochloride and mirtazapine), with the exception of fluoxetine, to be unfavourable for the treatment of major depressive disorders in children and adolescents.
In 2004, the US Food and Drug Administration convened a Psycho-pharmacology Advisory Committee, issued a public health advisory, and required black box warning labels for all antidepressants (including fluoxetine) highlighting the potential increase in suicidal thinking and behaviour in children and adolescents.
The warning recommended more intense therapeutic monitoring to mitigate these risks but did not suggest avoiding the paediatric use of antidepressants. Against such a background, doctors in Tennessee, US examined monthly antidepressant prescription data among patients age two to 17 years for a 45-month period.
The study months were divided into two periods. The period before the regulatory warnings included the 24 months from 1 January 2002 until 31 December 2003, and the period after the regulatory warnings– 21 months from 1 January 2004 until 30 September 2005. An average of 405,000 children and teens qualified for the study each month.
During the period before the regulatory warnings, there was little change from month to month in the rate of new antidepressant prescriptions, with an average of 23 per 10,000 patients. By the end of the study a total of 21 months after the UK warnings, this proportion had decreased by 33 per cent to an average of 15 per 10,000 per month.
The decrease was most pronounced for SSRIs (except for fluoxetine) and another type of antidepressant linked to suicidal thoughts and behaviours, selective norepinephrine reuptake inhibitors.
New users of fluoxetine, the only antidepressant approved by the FDA for the treatment of depression in children and adolescents, increased by 60 per cent. However, there was no evidence of an increase in discontinuation of therapy with antidepressant or other psychotropic drugs, which suggests that the primary effect of the warnings was to alter the decision to treat a newly presenting patient, the study’s authors observed.