Off-label Paediatric Drug Use for Juvenile Depression and the Clinical Trial Regulations 2004: The Impact of Available Protective Mechanisms

Abstract

Across Europe, around one in four adults experience a mental health problem in any 1 year. It is estimated that 2–6% of children and adolescents suffer from depression and suicide is now the third leading cause of death in 10–19 year olds. Despite traditional Freudian teachings that children rarely suffer from clinically diagnosed depression, treatment figures for juvenile depression have soared in recent years. For adults, the current treatment trend, as advocated by the National Institute for Health and Clinical Excellence (NICE), is the use of Selective Serotonin Reuptake Inhibitors (SSRIs), such as Prozac. For children, efficacy of such treatment remains difficult to judge as all SSRI use in paediatric care remains ‘off-label’ or unlicensed. Notwithstanding this, in 2006 the European Medicines Agency (EMEA) advocated the use of Prozac within the EU for children from the age of eight, a position that reinforced the stance adopted by NICE in 2005. These recommendations have been made despite growing concern that many SSRIs have some serious side effects. In new legislation for paediatric medicines, that came into effect on 26th January 2007, the European Union (EU) has attempted to address several unresolved issues relating to children’s needs for medicines in Europe. This paper considers the position of off-label drug-therapy for juvenile depression, and assesses the effectiveness of available legal mechanisms that can protect juveniles from harm when involved in clinical drug trials, most notably the Clinical Trial Regulations 2004. It further reviews the new EU legislation and evaluates its likely impact.