As anticipated, Europe’s drug regulator, the EMEA, yesterday called for stronger warnings to be placed on antidepressant labeling after a panel concluded that two classes of drug were linked to an increased risk of suicidal behaviour and hostility.
Doctors and patients will now be warned that antidepressants should not be used in children and adolescents other than in their approved indications. However, while doctors have not been banned from prescribing to this age group, the European agency is recommending that in these cases patients be monitored carefully for the appearance of suicidal behaviour, self-harm or hostility, particularly at the beginning of treatment.
The compounds under scrutiny included those from the serotonin-selective reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) classes and – while none are licensed for treating depression in children or adolescents - some have been cleared for combating paediatric obsessive-compulsive disorder and one is approved for treating attention deficit/hyperactivity disorder.
Last October, the US Food and Drug Administration ordered that all antidepressants – across all drug classes – be stamped with a black box warning of an increased risk of suicidal behaviour amongst children and adolescents [[18/10/04b]], [[15/09/04a]]. In the UK, doctors were banned from prescribing a number of antidepressants from the SSRI class to the under-18s in 2003 [[11/12/03b]].