The last 12 months have witnessed radical changes and considerable controversy regarding how childhood and teenage depression is treated. Although few antidepressant drugs have been licensed for pediatric use, rates of prescribing in the under-18 age group have risen by around 60% over the past decade, with over a million children and adolescents receiving what are called selective serotonin reuptake inhibitors (SSRI’s).
Now, however, concerns over these drugs’ safety and side effects in children and adolescents – including elevated suicide rates – have awakened regulators in many countries. After reviewing all relevant pediatric trials, the UK’s Medinces and Heathcare products Regulatory Agency (MHRA) advised that the risks outweighed the benefits for all SSRI’s (except fluoxetine), and that these products should not be prescribed as new therapy for patients under 18 years of age with depressive illness.
For the first time, the MHRA made public a summary of the review that this decision was based on, including both efficacy and safety data for all of the trials, regardless of whether they had previously been published or not. This was important because about half of the trials had not been published in peer-reviewed journals.
The pediatric trial data released by the MHRA presented a unique opportunity to examine whether the unpublished data supported the findings from published studies of SSRI’s. My colleagues and I addressed this question in a review published in The Lancet in April 2004. The review showed that while the published data generally indicated minimal risk, the unpublished trial data were far less sanguine, and even suggested an increased risk of serious adverse events, including suicide-related behavior.