Methodology and long-term follow-up of drug induced side effects in children (cancer, leukemia, AIDS, growth hormone)
Hoog-Labouret, N.; Lassale, C.; Eschwege, E.
Therapie 57(4): 322-328
2002
ISSN/ISBN: 0040-5957 PMID: 12422552 Document Number: 545898
Long-term follow up for medicines used in children is necessary in some therapeutic areas. Long-term effects (e.g. in cancer) may be detected many years after the treatment period. Growth, development and maturation specific to children can make these effects particularly harmful. The development plan of a paediatric drug should include, long term follow up on the basis of pharmacological-toxicological and safety data. These aspects should be taken into account when modifying the protocol (lower dosage, withdrawal of some associations etc). The follow up period may be very long, as in cancer (e.g. second tumour after treatment for cancer). A cohort is the best choice for this follow up, but other alternatives may be useful, including a specific follow-up Unit. Long-term follow-up is nevertheless difficult and expensive, manpower-dependent and the risk of failure is great especially in the teenage years.