Prior to the recommendations released by the FDA, the United Kingdom Department of Health issued a press release stating that paroxetine (UK trade name Seroxat) must not be used for the treatment of depressive illness in children under the age of 18 (June and September 2003). This recommendation was based on a thorough review of data that demonstrated the benefits of paroxetine in children do not outweigh the risks of self harm and potentially suicidal behavior.8 Based on the analyses conducted by the Committee on Safety of Medicines (CSM), it was found that the risk of self harm and suicidal behavior is increased 1.5 to 3.2 times over placebo.9 Their advice to clinicians was the following: paroxetine should not be started as new therapy for patients younger than 18 years of age, patients successfully treated with paroxetine should be encouraged to complete treatment, and, for those patients not doing well on paroxetine, then a change of treatment should be considered. In September, the same office issued a similar warning about the use of venlafaxine (UK trade name Efexor). Most recently, in a public health link issued December 10, 2003, the CSM reported on the completion of their review of the safety and efficacy of the SSRI class in the treatment of pediatric major depressive disorder. Their findings were as follows:
- • Paroxetine, venlafaxine, sertraline, citalopram and escitalopram are now contraindicated in paediatric MDD in the under 18s.
• There are no data on the safety and efficacy of fluvoxamine in paediatric MDD. Safety and efficacy in adults cannot be extrapolated to those under 18 and therefore this product should not be used in this age group.
• The balance of risks and benefits of fluoxetine in the treatment of MDD in under 18s appears to be favourable.