[Pharmacovigilance in children]

Drug safety in children must take into account the frequency of « off label » prescriptions, children's growth dynamics, and possible long-term consequences (growth, neurodevelopment). The pharmacovigilance methodology is based on spontaneous notification and pharmacoepidemiology studies usually included the in risk management plan. Despite an increased drug risk (pharmacokinetic and pharmacodynamic specificities), drug safety is better in children than in adults. The incidence of drug side effects depends on the country, the type of study (in or out of the hospital), and age. Antibiotics, central nervous, respiratory and dermatologic drug systems are most often involved. The target organs are gastrointestinal and neurologic. In neonates, the most frequent side effects are due to pregnancy exposure to psychotropic drugs, beta-blockers, and antiepileptics. Some studies have shown an increased risk of off-label prescriptions in children. During the last 6 years in France, pediatric alerts (desmopressin, metoclopramide, bronchial mucolytic drugs, first-generation anti-H1, Uvesterol D(®), and Uvesterol A.D.E.C(®), rotavirus vaccines, growth hormone, cisapride) have been less frequent than in adults.