Paediatric Protection

Most medicines used in children have not been assessed or developed properly, and about 50 to 85 per cent of drugs are not licensed for use in children. Despite the lack of sufficient information about a drug, clinicians are still willing to prescribe products off-label, carefully considering the risk and benefit ratio. The administered dosages of many drugs that are being used in children are calculated based on extrapolations from the adults’ drug doses using the respective child’s weight or age. However, this can be dangerous and possibly lead to underdosing, overdosing or specific adverse events. Over the years, we have come to appreciate that there are indeed differences between children and adults with respect to general metabolism, renal clearance, anatomy, physiology and drug metabolism. These differences have highlighted the fact that children are not just smaller adults, but that they actually have their own peculiarities (1). In the US, where paediatric regulation has been in place longer than in Europe, it can be observed that under FDAMA, important dosing changes and safety information have been added to drug labels, providing more information on dosing regimens and important adverse events warnings. One such example is that of Fluoxetine (Prozac), which had a major label change so that it now warns clinicians prescribing it that they should monitor the height and weight of the paediatric patients and administer the drug appropriately. Another case is that of Gabapentin, which, after paediatric studies were carried out, demonstrated that higher doses were required to control seizures in patients of a younger age group, and a new set of adverse events were recognised (2).