USA. The FDA has directed manufacturers of all antidepressant drugs to include a boxed warning and expanded warning statements in the labels of these products that alert health-care providers to an increased risk of suicidality in children and adolescents treated with these products and to include additional information about the results of paediatric studies. All drugs included in the general class of antidepressants will have this new boxed and expanded labelling. The risk of suicidality was identified in a combined analysis of short-term placebo-controlled trials of nine antidepressant drugs, including the selective serotonin reuptake inhibitors (SSRIs), in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD) or other psychiatric disorders. The analysis showed a greater risk of suicidality during the first few months of treatment in those receiving antidepressants. The average risk of such events on drug was 4%, twice the placebo risk of 2 %. According to the FDA Public Health Advisory, the expanded warning statements will highlight the following:
• Antidepressants increase the risk of suicidal thinking and behaviour (suicidality) in children and adolescents with MDD and other psychiatric disorders.
• Anyone considering the use of an antidepressant in a child or adolescent for any clinical use must balance the risk of increased suicidality with the clinical need.
• Patients on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behaviour.
• Families and caregivers should be advised to closely observe the patient and to communicate with the prescriber.
• A statement regarding whether the particular drug is approved for any paediatric indication(s) and, if so, which one(s).
The FDA has advised that a Patient Medication Guide (MedGuide) should be given to all patients receiving the drugs to provide information to patients and their families and caregivers about the risk of suicidality in children and adolescents. MedGuides are intended to be distributed by the pharmacist with each prescription or refill of a medication.
FDA Public Health Advisory, 15 October 2004. Available on the Internet at www.fda.gov