Safety of Medicines in Children
It has long been recognised that children and particularly very young children differ from adults in their response to drugs. At the time of marketing there is often limited information about the use of drugs in the paediatric population. However there may be clinical need for the use of ‘new’ medicines in the young and there is widespread concern over the use of ‘unlicensed’ or ‘off label’ medicines in children and adolescents.
In many of the studies, conducted by the DSRU, the drug being monitored will have been used in those aged <18years. The number of children/adolescents identified in the study cohort varies depending on the drug. Analyses are often undertaken to compare the event rates in the paediatric population to those in the adult population, to ascertain whether the event profile in the children/adolescents is similar to or differs from that in the adult population. In the past, the DSRU have identified differences in the rates of specific events in children and adults treated with anti-epileptic medications. We have published a study in which the licensed and ‘off label’ use of newly marketed medicines in children and adolescents was investigated.
Publication:
Martin RM, Wilton LV, Mann RD, Steventon P, Hilton SR. Unlicensed and off label drug use for paediatric patients. General practitioners prescribe SSRIs to children off label. BMJ. 1998 Jul 18;317(7152):204.