Adverse drug reaction monitoring in pediatric practice.

Children constitute a vulnerable group since a new drug gets released to the market without the benefit of even limited experience in them. Adequate controlled clinical trials in children, with the notable exceptions of pediatric oncology and vaccinations, are lacking because of ethical considerations. Only a vigilant postmarketing surveillance detects ADRs occurring uniquely in children, for example, sulfonamide induced kernicterus in premature infants(3), chloramphenicol induced "gray syndrome "(4), and phenytoin induced movement disorders(5).