Opening the white boxes: the licensing documentation of efficacy and safety of psychotropic medicines for children

Purpose The objective of the present study was to explore the available evidence in a regulatory agency on the safety and efficacy of two types of psychotropic medicine frequently prescribed to children and adolescents. Methods We analysed the documentation in registration files, renewal registration files, summaries of product characteristics and scientific assessment reports in the Danish Medicines Agency for two psychotropic medications prescribed for children: methylphenidate and citalopram to discover what data pertaining to the pediatric population are available to the regulatory agency. Results The licensing of methylphenidate for treating attention-deficit hyperactivity disorders (ADHD) in children from the age of six was based on a single-dose crossover study and, a 2-week double blind, parallel group clinical trial in 100 patients from ages 6 to 12 and published literature. Citalopram is not licensed for pediatric use in Denmark. Citalopram was being investigated in three ongoing clinical trials lasting 824 weeks in 423 patients aged 7-18 years. The registration files contained no data on the long-term efficacy and safety of citalopram in pediatric use. Registration material also contained information on planned clinical trials with methylphenidate and citalopram among children/adolescents. Conclusions Evidence on the efficacy and safety of methylphenidate and citalopram for pediatric use in the Danish Medicine Agency is limited and supports the need for further clinical trials. Medicine prescription for the pediatric population should be monitored in order to identify risks that were not identified at the time of licensing. The results of clinical trials already conducted should be made publicly available. Copyright (C) 2009 John Wiley & Sons, Ltd.